<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/NCT02968602</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00072110</org_study_id>
    <secondary_id>4K23DA034034-04</secondary_id>
    <nct_id>NCT02968602</nct_id>
  </id_info>
  <brief_title>Minocycline and Tobacco Craving in Smokers With Schizophrenia</brief_title>
  <official_title>Minocycline and Tobacco Craving in Smokers With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</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>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Craving for cigarettes is an important aspect that leads to challenges with smoking&#xD;
      cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than&#xD;
      persons without schizophrenia, and may experience craving differently as well. Minocycline is&#xD;
      an antibiotic medication that may impact craving. We will conduct a two-week randomized,&#xD;
      double-blind, placebo-controlled, parallel group pilot study to investigate the effects of&#xD;
      minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia.&#xD;
      Participants will take minocycline or matching placebo for two weeks. Participants will be&#xD;
      assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of&#xD;
      minocycline or placebo treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nicotine dependence is high in schizophrenia; nearly three times more prevalent than the&#xD;
      general population. In smokers with schizophrenia, the risk of all-cause mortality is doubled&#xD;
      and cardiovascular mortality risk is twelvefold higher than nonsmokers. Many factors&#xD;
      influence smoking in persons with schizophrenia, but predictors of craving and smoking&#xD;
      behavior are not well established. Craving is a major contributor to smoking behaviors, and,&#xD;
      importantly, is a predictor of relapse risk. Since craving may precede relapse, it can be&#xD;
      advantageous as a screening tool for those attempting cessation. In addition, focusing on&#xD;
      treatments aimed to reduce craving may lead to better therapeutic targets. Minocycline may&#xD;
      affect craving, perhaps due to inhibition of nitric oxide (NO) formation, as NO acts as a&#xD;
      second messenger for glutamate and dopamine receptors. NO also facilitates the effects of&#xD;
      nicotine in the reward circuit, and blockade of NO has been demonstrated to eliminate&#xD;
      nicotine abstinence symptoms in rats. A small study has demonstrated that minocycline reduces&#xD;
      cigarette craving in human subjects without severe mental illness. The investigators will&#xD;
      conduct a two-week randomized, double-blind, placebo-controlled, parallel group pilot study&#xD;
      to investigate the effects of minocycline vs. placebo on craving and indicators of smoking&#xD;
      intensity in smokers with schizophrenia. Participants will take minocycline up to 200 mg&#xD;
      daily or matching placebo for two weeks. Participants will complete cigarette cue-elicited&#xD;
      craving platforms and related assessments at baseline, and after 1 and 2 weeks of minocycline&#xD;
      or placebo treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Actual">July 23, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 2019</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire for Smoking Urges-Brief</measure>
    <time_frame>Baseline, Week 1, and Week 2</time_frame>
    <description>This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Tobacco Use</condition>
  <arm_group>
    <arm_group_label>Minocycline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minocycline</intervention_name>
    <description>Minocycline capsules taken twice daily for two weeks.</description>
    <arm_group_label>Minocycline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsules taken twice daily for two weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  DSM-IV or DSM-5 diagnosis of schizophrenia or schizoaffective disorder&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  Age: 18 to 65 years&#xD;
&#xD;
          -  Caucasian or Non-Caucasian&#xD;
&#xD;
          -  Smoke at least 10 cigarettes daily&#xD;
&#xD;
          -  Urine cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)&#xD;
&#xD;
          -  Agrees to wear a head mounted display (HMD) for up to 45 minutes&#xD;
&#xD;
          -  Able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80%&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  History of organic brain disease&#xD;
&#xD;
          -  DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except&#xD;
             nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except&#xD;
             nicotine)&#xD;
&#xD;
          -  DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except&#xD;
             nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except&#xD;
             nicotine)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Severe liver dysfunction (LFT 3X upper limit of normal)&#xD;
&#xD;
          -  Previous known hypersensitivity to tetracyclines&#xD;
&#xD;
          -  Current treatment with tetracycline or derivative&#xD;
&#xD;
          -  Treatment with oral contraceptives (unless a second form of birth control is used and&#xD;
             documented)&#xD;
&#xD;
          -  Treatment with cholestyramine or colestipol&#xD;
&#xD;
          -  Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)&#xD;
&#xD;
          -  Treatment with warfarin&#xD;
&#xD;
          -  Treatment with bupropion, varenicline, or nicotine replacement products in the month&#xD;
             prior to study inclusion&#xD;
&#xD;
          -  Less than two months treatment of adjunctive medications AND less than one month on&#xD;
             same dose: beta blockers, antidepressants, mood stabilizers, antianxiety medications.&#xD;
&#xD;
          -  Medical condition whose pathology or treatment would significantly increase the risk&#xD;
             associated with the proposed protocol.&#xD;
&#xD;
          -  History of head injury, seizures, or stroke&#xD;
&#xD;
          -  Positive urine toxicology screen for substances of non-therapeutic use prior to&#xD;
             craving assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maryland Psyciatric Research Center</name>
      <address>
        <city>Catonsville</city>
        <state>Maryland</state>
        <zip>21228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>August 5, 2021</results_first_submitted>
  <results_first_submitted_qc>September 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 21, 2021</results_first_posted>
  <last_update_submitted>January 4, 2022</last_update_submitted>
  <last_update_submitted_qc>January 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Deanna Kelly</investigator_full_name>
    <investigator_title>Professor, Chief Treatment Research Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minocycline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This study was funded prior to the NIH requirements for sharing of IPD, therefore is not within our budget.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT02968602/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Minocycline</title>
          <description>Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.&#xD;
Minocycline: Minocycline capsules taken twice daily for two weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.&#xD;
Placebo: Placebo capsules taken twice daily for two weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Minocycline</title>
          <description>Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.&#xD;
Minocycline: Minocycline capsules taken twice daily for two weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.&#xD;
Placebo: Placebo capsules taken twice daily for two weeks.</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="16"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>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="43.43" spread="11.32"/>
                    <measurement group_id="B2" value="43.38" spread="8.22"/>
                    <measurement group_id="B3" value="43.4" spread="9.74"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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>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="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Questionnaire for Smoking Urges-Brief</title>
        <description>This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.</description>
        <time_frame>Baseline, Week 1, and Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Minocycline</title>
            <description>Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.&#xD;
Minocycline: Minocycline capsules taken twice daily for two weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.&#xD;
Placebo: Placebo capsules taken twice daily for two weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Questionnaire for Smoking Urges-Brief</title>
          <description>This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1429" spread="16.23319"/>
                    <measurement group_id="O2" value="38.6429" spread="18.46663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to week 2 (Endpoint)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4286" spread="18.03720"/>
                    <measurement group_id="O2" value="36.8571" spread="17.81467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Minocycline</title>
          <description>Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.&#xD;
Minocycline: Minocycline capsules taken twice daily for two weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.&#xD;
Placebo: Placebo capsules taken twice daily for two weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="7" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypersalavation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Loss of Appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Uticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Somatic Concern</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hostility</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>&quot;Zoning out&quot;</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Heidi J Wehring</name_or_title>
      <organization>Maryland Psychiatric Research Center</organization>
      <phone>410-402-6854</phone>
      <email>hwehring@som.umaryland.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/NCT02968602
org study id: HP-00072110
secondary id: 4K23DA034034-04
nct id: NCT02968602
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Craving for cigarettes is an important aspect that leads to challenges with smoking
      cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than
      persons without schizophrenia, and may experience craving differently as well. Minocycline is
      an antibiotic medication that may impact craving. We will conduct a two-week randomized,
      double-blind, placebo-controlled, parallel group pilot study to investigate the effects of
      minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia.
      Participants will take minocycline or matching placebo for two weeks. Participants will be
      assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of
      minocycline or placebo treatment.
Nicotine dependence is high in schizophrenia; nearly three times more prevalent than the
      general population. In smokers with schizophrenia, the risk of all-cause mortality is doubled
      and cardiovascular mortality risk is twelvefold higher than nonsmokers. Many factors
      influence smoking in persons with schizophrenia, but predictors of craving and smoking
      behavior are not well established. Craving is a major contributor to smoking behaviors, and,
      importantly, is a predictor of relapse risk. Since craving may precede relapse, it can be
      advantageous as a screening tool for those attempting cessation. In addition, focusing on
      treatments aimed to reduce craving may lead to better therapeutic targets. Minocycline may
      affect craving, perhaps due to inhibition of nitric oxide (NO) formation, as NO acts as a
      second messenger for glutamate and dopamine receptors. NO also facilitates the effects of
      nicotine in the reward circuit, and blockade of NO has been demonstrated to eliminate
      nicotine abstinence symptoms in rats. A small study has demonstrated that minocycline reduces
      cigarette craving in human subjects without severe mental illness. The investigators will
      conduct a two-week randomized, double-blind, placebo-controlled, parallel group pilot study
      to investigate the effects of minocycline vs. placebo on craving and indicators of smoking
      intensity in smokers with schizophrenia. Participants will take minocycline up to 200 mg
      daily or matching placebo for two weeks. Participants will complete cigarette cue-elicited
      craving platforms and related assessments at baseline, and after 1 and 2 weeks of minocycline
      or placebo treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Questionnaire for Smoking Urges-Brief
time frame: Baseline, Week 1, and Week 2
description: This is a 10-item assessment used to measure craving to smoke and used in studies of smokers with schizophrenia. This scale has a score range from 0-100The change in QSU-Brief craving scores between time points (baseline to week 1, and baseline to week 2) will be assessed. The change in scores between the two timepoints will be calculated. The higher the score the stronger the urge to smoke is.
arm group label: Minocycline
arm group type: Experimental
description: Participants will take 50 mg minocycline capsules twice daily for 1 week, then take 100 mg capsules twice daily for 1 week.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will take capsules that match active drug, but contain no active ingredients, twice daily for week 1, and then will take capsules that match active drug, but contain no active ingredients, twice daily for week 2.
intervention type: Drug
intervention name: Minocycline
description: Minocycline capsules taken twice daily for two weeks.
arm group label: Minocycline
intervention type: Other
intervention name: Placebo
description: Placebo capsules taken twice daily for two weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Deanna Kelly
investigator title: Professor, Chief Treatment Research Program
mesh term: Schizophrenia
mesh term: Minocycline
sharing ipd: No
ipd description: This study was funded prior to the NIH requirements for sharing of IPD, therefore is not within our budget.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 