<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675661</url>
  </required_header>
  <id_info>
    <org_study_id>CTN-0053</org_study_id>
    <secondary_id>U10DA013727</secondary_id>
    <secondary_id>UG1DA013727</secondary_id>
    <secondary_id>U10DA013045</secondary_id>
    <secondary_id>U10DA015815</secondary_id>
    <secondary_id>U10DA013732</secondary_id>
    <secondary_id>U10DA015831</secondary_id>
    <secondary_id>U10DA020024</secondary_id>
    <nct_id>NCT01675661</nct_id>
  </id_info>
  <brief_title>Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment</brief_title>
  <acronym>ACCENT</acronym>
  <official_title>Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200&#xD;
      mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on&#xD;
      cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this Phase 3 study is to evaluate the impact of NAC 1200 mg versus&#xD;
      matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use&#xD;
      among treatment-seeking cannabis-dependent adults (ages 18-50). After assessment and&#xD;
      inclusion into the study, participants will be randomized to receive a 12-week course of NAC&#xD;
      1200 mg or matched placebo twice daily. All participants will concurrently participate in a&#xD;
      twice-weekly contingency management (CM) intervention. Medication management will be&#xD;
      conducted weekly throughout treatment by the medical clinician. Urine cannabinoid testing&#xD;
      will occur at all visits, and will be used as the primary determinant of cannabis use.&#xD;
      Participants will return approximately four weeks after treatment conclusion for evaluation&#xD;
      of adverse events with medication discontinuation and sustained treatment effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Odds of Negative Urine Cannabinoid Tests During Treatment.</measure>
    <time_frame>study weeks 2-13</time_frame>
    <description>The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Cannabis Dependence</condition>
  <arm_group>
    <arm_group_label>NAC plus CM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>N-acetylcysteine (NAC) plus Contingency Management (CM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo plus CM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo plus Contingency Management (CM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-Acetylcysteine</intervention_name>
    <description>Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
    <arm_group_label>NAC plus CM</arm_group_label>
    <other_name>NAC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
    <arm_group_label>Placebo plus CM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-50 years&#xD;
&#xD;
          -  Must be able to understand the study and provide written informed consent&#xD;
&#xD;
          -  Must meet current DSM-IV criteria for cannabis dependence in the last 30 days&#xD;
&#xD;
          -  Must express interest in treatment for cannabis dependence&#xD;
&#xD;
          -  Must submit a positive urine cannabinoid test during screening&#xD;
&#xD;
          -  Women of child bearing potential must agree to use appropriate birth control methods&#xD;
             during study participation: oral contraceptives, contraceptive patch, barrier&#xD;
             (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete&#xD;
             abstinence from sexual intercourse, or hormonal contraceptive vaginal ring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or intolerance to N-Acetylcysteine&#xD;
&#xD;
          -  Women who are pregnant or lactating&#xD;
&#xD;
          -  Current use of NAC or any supplement containing N-Acetylcysteine (must agree not to&#xD;
             take any such supplement throughout study participation)&#xD;
&#xD;
          -  Use of carbamazepine or nitroglycerin within 14 days of randomization&#xD;
&#xD;
          -  Current enrollment in treatment for cannabis dependence&#xD;
&#xD;
          -  Any use of synthetic cannabinoids (such as K2/Spice) in the 30 days prior to screening&#xD;
             or during the period between screening and randomization&#xD;
&#xD;
          -  Current substance dependence, other than cannabis or nicotine&#xD;
&#xD;
          -  Urine drug screen positive for any drug of abuse other than cannabis or amphetamines&#xD;
             at the randomization visit (Only participants who have a valid prescription for&#xD;
             amphetamines (e.g., for ADHD) may be included)&#xD;
&#xD;
          -  Urine drug screen positive for amphetamines at the randomization visit without having&#xD;
             a valid prescription for it&#xD;
&#xD;
          -  Maintenance treatment with buprenorphine or methadone&#xD;
&#xD;
          -  Recent history of asthma (within the last 3 years)&#xD;
&#xD;
          -  History of seizure disorder, bipolar disorder, schizophrenia, or other significant or&#xD;
             unstable medical or psychiatric illness that may place the participant at increased&#xD;
             risk in the judgment of the medical clinician&#xD;
&#xD;
          -  Significant risk of homicide or suicide&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin M Gray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Integrated Substance Abuse Programs</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APT Foundation, Inc.</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CODA, Inc.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Health Services of Pickens County</name>
      <address>
        <city>Pickens</city>
        <state>South Carolina</state>
        <zip>29671</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>McClure EA, Sonne SC, Winhusen T, Carroll KM, Ghitza UE, McRae-Clark AL, Matthews AG, Sharma G, Van Veldhuisen P, Vandrey RG, Levin FR, Weiss RD, Lindblad R, Allen C, Mooney LJ, Haynes L, Brigham GS, Sparenborg S, Hasson AL, Gray KM. Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network. Contemp Clin Trials. 2014 Nov;39(2):211-23. doi: 10.1016/j.cct.2014.08.011. Epub 2014 Aug 30.</citation>
    <PMID>25179587</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>January 18, 2017</results_first_submitted>
  <results_first_submitted_qc>January 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2017</results_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Kevin Gray, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The lead investigator will submit coded individual level data on Clinical Trials Network (CTN) study participants to the Data Management Center contracted by NIDA Center for CTN. These data may include but are not limited to: demographic information, date of birth, medical history, substance use history, psychiatric history, objective measures of substance use and psychiatric status, HIV status and genetic information. Data will be submitted without information that could readily identify the study participant (i.e. We will not share medical record numbers, social security numbers or participant names or phone numbers with the Data Management Center). De-identified data will be made publicly available per the CTN's policies.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment occurred almost exclusively through advertising. Individuals currently in treatment for cannabis dependence were not eligible to participate</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>NAC Plus CM</title>
          <description>N-acetylcysteine (NAC) plus Contingency Management (CM)&#xD;
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Plus CM</title>
          <description>Placebo plus Contingency Management (CM)&#xD;
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
                <participants group_id="P2" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Practical problems</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved away</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NAC Plus CM</title>
          <description>N-acetylcysteine (NAC) plus Contingency Management (CM)&#xD;
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Plus CM</title>
          <description>Placebo plus Contingency Management (CM)&#xD;
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="153"/>
            <count group_id="B2" value="149"/>
            <count group_id="B3" value="302"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.8" spread="8.74"/>
                    <measurement group_id="B2" value="30.8" spread="9.32"/>
                    <measurement group_id="B3" value="30.3" spread="9.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="237"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Odds of Negative Urine Cannabinoid Tests During Treatment.</title>
        <description>The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.</description>
        <time_frame>study weeks 2-13</time_frame>
        <population>Intent to treat; all participants randomized</population>
        <group_list>
          <group group_id="O1">
            <title>NAC Plus CM</title>
            <description>N-acetylcysteine (NAC) plus Contingency Management (CM)&#xD;
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Plus CM</title>
            <description>Placebo plus Contingency Management (CM)&#xD;
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
          </group>
        </group_list>
        <measure>
          <title>The Odds of Negative Urine Cannabinoid Tests During Treatment.</title>
          <description>The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.</description>
          <population>Intent to treat; all participants randomized</population>
          <units>cannabis negative urine tests</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Study Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410"/>
                    <measurement group_id="O2" value="401"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.985</p_value>
            <method>Regression, Logistic</method>
            <method_desc>OR=1.00</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>1.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.</time_frame>
      <desc>Participants were asked once a week</desc>
      <group_list>
        <group group_id="E1">
          <title>NAC Plus CM</title>
          <description>N-acetylcysteine (NAC) plus Contingency Management (CM)&#xD;
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Plus CM</title>
          <description>Placebo plus Contingency Management (CM)&#xD;
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Irregular Heart Rate</sub_title>
                <description>Inpatient admission for irregular heart beat; resolved without sequelae</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <description>Inpatient admission for lower extremity cellulitis-resolved without sequelae</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road Traffic Accident</sub_title>
                <description>Death due to motor vehicle accident</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <description>Inpatient hospitalization for herniated disc; resolved without sequelae</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <description>Inpatient hospitalization for suicidal ideation; resolved without sequelae</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysfunctional Uterine Bleeding</sub_title>
                <description>Inpatient hospitalization for dysfunctional uterine bleeding; resolved without sequelae</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <description>Inpatient hospitalization for acute exacerbation of asthma</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="153"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Frequent Bowel Movements</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Energy increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Localized infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Groin Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Human bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Hand Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Back Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="153"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Elevated mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Alcohol abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>All publications/dissemination products must be reviewed and approved by the Center for Clinical Trials Network (CCTN) Publications Committee before publishing/disseminating.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kevin Gray, MD</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>843-792-6330</phone>
      <email>graykm@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675661
org study id: CTN-0053
secondary id: U10DA013727
secondary id: UG1DA013727
secondary id: U10DA013045
secondary id: U10DA015815
secondary id: U10DA013732
secondary id: U10DA015831
secondary id: U10DA020024
nct id: NCT01675661
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200
      mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on
      cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).
The primary objective of this Phase 3 study is to evaluate the impact of NAC 1200 mg versus
      matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use
      among treatment-seeking cannabis-dependent adults (ages 18-50). After assessment and
      inclusion into the study, participants will be randomized to receive a 12-week course of NAC
      1200 mg or matched placebo twice daily. All participants will concurrently participate in a
      twice-weekly contingency management (CM) intervention. Medication management will be
      conducted weekly throughout treatment by the medical clinician. Urine cannabinoid testing
      will occur at all visits, and will be used as the primary determinant of cannabis use.
      Participants will return approximately four weeks after treatment conclusion for evaluation
      of adverse events with medication discontinuation and sustained treatment effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Odds of Negative Urine Cannabinoid Tests During Treatment.
time frame: study weeks 2-13
description: The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.
arm group label: NAC plus CM
arm group type: Active Comparator
description: N-acetylcysteine (NAC) plus Contingency Management (CM)
arm group label: Placebo plus CM
arm group type: Placebo Comparator
description: Placebo plus Contingency Management (CM)
intervention type: Drug
intervention name: N-Acetylcysteine
description: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
arm group label: NAC plus CM
other name: NAC
intervention type: Drug
intervention name: Placebo
description: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
arm group label: Placebo plus CM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Kevin M Gray, MD
role: Principal Investigator
affiliation: Associate Professor, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: McClure EA, Sonne SC, Winhusen T, Carroll KM, Ghitza UE, McRae-Clark AL, Matthews AG, Sharma G, Van Veldhuisen P, Vandrey RG, Levin FR, Weiss RD, Lindblad R, Allen C, Mooney LJ, Haynes L, Brigham GS, Sparenborg S, Hasson AL, Gray KM. Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network. Contemp Clin Trials. 2014 Nov;39(2):211-23. doi: 10.1016/j.cct.2014.08.011. Epub 2014 Aug 30.
PMID: 25179587
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Kevin Gray, MD
investigator title: Associate Professor
mesh term: Marijuana Abuse
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine
sharing ipd: Yes
ipd description: The lead investigator will submit coded individual level data on Clinical Trials Network (CTN) study participants to the Data Management Center contracted by NIDA Center for CTN. These data may include but are not limited to: demographic information, date of birth, medical history, substance use history, psychiatric history, objective measures of substance use and psychiatric status, HIV status and genetic information. Data will be submitted without information that could readily identify the study participant (i.e. We will not share medical record numbers, social security numbers or participant names or phone numbers with the Data Management Center). De-identified data will be made publicly available per the CTN's policies.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 