<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/NCT01723527</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DA033510-01</org_study_id>
    <nct_id>NCT01723527</nct_id>
  </id_info>
  <brief_title>Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</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>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      More Americans are arrested for drug offenses than for any other crime. In 2009, over 294,000&#xD;
      arrests were made for possession of cocaine or heroin. Incarceration does not address the&#xD;
      root problems and is frequently followed by relapse and re-arrest after release. In the case&#xD;
      of opiate-dependent adults arrested for possession of heroin, one potentially effective&#xD;
      alternative is to divert offenders to methadone maintenance treatment (MMT) as an alternative&#xD;
      to adjudication of their case. MMT is an effective treatment for heroin dependence, and&#xD;
      appears very effective for criminal offenders. However, cocaine use is common in MMT&#xD;
      patients, including those with recent criminal justice involvement, and MMT alone is&#xD;
      ineffective in addressing cocaine use. Continued cocaine use carries a substantial health&#xD;
      burden and necessarily entails continued criminal activity. Thus, treatment for diverted&#xD;
      opiate-dependent offenders should be designed to address cocaine use as well as opiate use. A&#xD;
      Stage 1 Behavior Therapy Development project is planned over 2 years to adapt, manualize and&#xD;
      pilot test the Therapeutic Workplace intervention for adults charged with heroin possession&#xD;
      and offered diversion to methadone maintenance treatment as an alternative to adjudication of&#xD;
      their case. The Therapeutic Workplace is a novel, employment-based contingency management&#xD;
      intervention that has been very effective in promoting cocaine abstinence in adults who use&#xD;
      cocaine persistently during methadone treatment. In the Therapeutic Workplace, participants&#xD;
      are hired in a model workplace and required to provide drug-free urine samples to work and to&#xD;
      earn maximum pay. Once we develop and manualize the adapted version of the Therapeutic&#xD;
      Workplace for adults arrested for heroin possession, a pilot test will be conducted.&#xD;
      Individuals identified by the State Attorney's office as candidates for diversion will be&#xD;
      assessed for study eligibility. Given the high rates of injection drug use and&#xD;
      injection-related transmission of HIV in Baltimore, this study will be restricted to&#xD;
      injection drug users to evaluate the potential utility of this intervention in reducing HIV&#xD;
      risk. Eligible individuals will be offered methadone maintenance in lieu of prosecution and&#xD;
      will be required to remain in methadone treatment for 90 days. All participants will receive&#xD;
      standard MMT, independent of whether they decide to participate in the pilot study. After&#xD;
      beginning MMT, participants will be invited to enroll in the pilot study and randomly&#xD;
      assigned to two study groups. Participants assigned to the Usual Care Diversion group will&#xD;
      receive the standard MMT. Participants assigned to the Therapeutic Workplace Enhanced&#xD;
      Diversion group will receive the standard MMT and the Therapeutic Workplace intervention. The&#xD;
      data from this pilot study will serve as the foundation for a full-scaled randomized&#xD;
      controlled trial. Overall, the Therapeutic Workplace could serve as a novel and ideal&#xD;
      intervention for many heroin dependent adults involved in the criminal justice system. The&#xD;
      use of MMT in lieu of adjudication in combination with the Therapeutic Workplace could&#xD;
      increase drug abstinence and employment and decrease HIV risk and criminal activity in this&#xD;
      refractory high-risk population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cocaine abstinence as assessed by urinalysis</measure>
    <time_frame>One year</time_frame>
    <description>dichotomous (Y/N)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cocaine abstinence as assessed by self-reports</measure>
    <time_frame>One year</time_frame>
    <description>dichotomous (Y/N)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Any drug use (Y/N)</measure>
    <time_frame>One year</time_frame>
    <description>Any drug use will be counted as Yes if a urine sample indicates that the participant is positive for any of the DOT 5 drugs, or if the participant reports using any of the DOT 5 drugs (Amphetamines, Cocaine, Marijuana, Opiates, PCP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any engagement in HIV risk behavior (Y/N)</measure>
    <time_frame>One year</time_frame>
    <description>Any engagement in HIV risk behavior will be counted as Yes if a participant reports any unprotected vaginal or anal sex or reports any injection drug use that includes the sharing of injection equipment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any criminal activity (Y/N)</measure>
    <time_frame>One year</time_frame>
    <description>Criminal activity will counted as Yes if a participant reports any days of illegal activity in the previous 30 days, or has been arrested for any new crime in the previous 30 days according to publically available records maintained by the Maryland DPSCS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Cocaine-Related Disorders</condition>
  <condition>HIV</condition>
  <condition>Heroin Dependence</condition>
  <arm_group>
    <arm_group_label>Therapeutic Workplace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this condition will receive the standard services and requirements for diversion as described for the usual care group, and will also be eligible to attend the three-phase Therapeutic Workplace (TW) intervention. All phases of this intervention include employment-based drug abstinence reinforcement contingencies. Under these contingencies, participants can work and earn wages or wage subsidies contingent upon drug abstinence as verified by urinalysis. Phase 1 of the TW intervention is expected to increase cocaine abstinence and to prepare participants for employment. Phase 2 of the TW intervention is expected to maintain abstinence while participants are employed in an onsite model workplace. Phase 3 is designed to increase employment in community jobs and to maintain abstinence while participants are employed in offsite community workplaces.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diversion to treatment (Usual Care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this condition will be offered the standard treatment services available in community methadone and buprenorphine programs, including medication (methadone or buprenorphine, respectively), counseling services, HIV testing, and case management. All services will be provided in the treatment clinics. There are a number of clinics within easy walking distance from the research site, and others throughout the city that are reachable by public transportation from the research site. In addition, all participants will receive referrals to the Re-Entry Center, a One-Stop Career Center tailored to the needs of offenders, at all intake and monthly assessments. As mentioned in detail above, participants will be required by the court to stay enrolled in treatment for 90 days. It is important to note that all diverted individuals will receive these services and requirements, independent of whether they agree to participate in the pilot study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methadone</intervention_name>
    <description>Clinic-Based Methadone Maintenance Treatment</description>
    <arm_group_label>Diversion to treatment (Usual Care)</arm_group_label>
    <arm_group_label>Therapeutic Workplace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine</intervention_name>
    <description>Clinic-Based Buprenorphine Maintenance Treatment</description>
    <arm_group_label>Diversion to treatment (Usual Care)</arm_group_label>
    <arm_group_label>Therapeutic Workplace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Employment-based drug abstinence reinforcement</intervention_name>
    <arm_group_label>Therapeutic Workplace</arm_group_label>
    <other_name>Therapeutic Workplace</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  report using heroin at least 20 of the last 30 days of living in the community&#xD;
&#xD;
          -  meet criteria for methadone maintenance (at least one year of meeting DSM IV criteria&#xD;
             for heroin dependence)&#xD;
&#xD;
          -  have visible track marks or other clear physical evidence of injection drug use&#xD;
&#xD;
          -  report using cocaine in the last 30 days&#xD;
&#xD;
          -  were unemployed prior to arrest&#xD;
&#xD;
          -  have a income below the federal poverty level&#xD;
&#xD;
          -  live in the Baltimore City area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  report current suicidal ideation or hallucinations&#xD;
&#xD;
          -  receiving opioid pharmacotherapy prior to arrest&#xD;
&#xD;
          -  have a serious uncontrolled medical condition that would prevent attendance in&#xD;
             methadone or buprenorphine treatment&#xD;
&#xD;
          -  are pregnant or breastfeeding&#xD;
&#xD;
          -  have a physical imparement that would prevent typing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony DeFulio, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Learning and Health</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>December 10, 2014</last_update_submitted>
  <last_update_submitted_qc>December 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Anthony DeFulio</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cocaine</keyword>
  <keyword>Heroin</keyword>
  <keyword>HIV</keyword>
  <keyword>Contingency Management</keyword>
  <keyword>Incentives</keyword>
  <keyword>Criminal Justice</keyword>
  <keyword>Methadone</keyword>
  <keyword>Buprenorphine</keyword>
  <keyword>Employment</keyword>
  <keyword>Job Training</keyword>
  <keyword>Wage Subsidies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
    <mesh_term>Heroin Dependence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Methadone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01723527
org study id: 1R34DA033510-01
nct id: NCT01723527
lead sponsor: 
collaborator: 
has dmc: Yes
More Americans are arrested for drug offenses than for any other crime. In 2009, over 294,000
      arrests were made for possession of cocaine or heroin. Incarceration does not address the
      root problems and is frequently followed by relapse and re-arrest after release. In the case
      of opiate-dependent adults arrested for possession of heroin, one potentially effective
      alternative is to divert offenders to methadone maintenance treatment (MMT) as an alternative
      to adjudication of their case. MMT is an effective treatment for heroin dependence, and
      appears very effective for criminal offenders. However, cocaine use is common in MMT
      patients, including those with recent criminal justice involvement, and MMT alone is
      ineffective in addressing cocaine use. Continued cocaine use carries a substantial health
      burden and necessarily entails continued criminal activity. Thus, treatment for diverted
      opiate-dependent offenders should be designed to address cocaine use as well as opiate use. A
      Stage 1 Behavior Therapy Development project is planned over 2 years to adapt, manualize and
      pilot test the Therapeutic Workplace intervention for adults charged with heroin possession
      and offered diversion to methadone maintenance treatment as an alternative to adjudication of
      their case. The Therapeutic Workplace is a novel, employment-based contingency management
      intervention that has been very effective in promoting cocaine abstinence in adults who use
      cocaine persistently during methadone treatment. In the Therapeutic Workplace, participants
      are hired in a model workplace and required to provide drug-free urine samples to work and to
      earn maximum pay. Once we develop and manualize the adapted version of the Therapeutic
      Workplace for adults arrested for heroin possession, a pilot test will be conducted.
      Individuals identified by the State Attorney's office as candidates for diversion will be
      assessed for study eligibility. Given the high rates of injection drug use and
      injection-related transmission of HIV in Baltimore, this study will be restricted to
      injection drug users to evaluate the potential utility of this intervention in reducing HIV
      risk. Eligible individuals will be offered methadone maintenance in lieu of prosecution and
      will be required to remain in methadone treatment for 90 days. All participants will receive
      standard MMT, independent of whether they decide to participate in the pilot study. After
      beginning MMT, participants will be invited to enroll in the pilot study and randomly
      assigned to two study groups. Participants assigned to the Usual Care Diversion group will
      receive the standard MMT. Participants assigned to the Therapeutic Workplace Enhanced
      Diversion group will receive the standard MMT and the Therapeutic Workplace intervention. The
      data from this pilot study will serve as the foundation for a full-scaled randomized
      controlled trial. Overall, the Therapeutic Workplace could serve as a novel and ideal
      intervention for many heroin dependent adults involved in the criminal justice system. The
      use of MMT in lieu of adjudication in combination with the Therapeutic Workplace could
      increase drug abstinence and employment and decrease HIV risk and criminal activity in this
      refractory high-risk population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cocaine abstinence as assessed by urinalysis
time frame: One year
description: dichotomous (Y/N)
measure: Cocaine abstinence as assessed by self-reports
time frame: One year
description: dichotomous (Y/N)
measure: Any drug use (Y/N)
time frame: One year
description: Any drug use will be counted as Yes if a urine sample indicates that the participant is positive for any of the DOT 5 drugs, or if the participant reports using any of the DOT 5 drugs (Amphetamines, Cocaine, Marijuana, Opiates, PCP).
measure: Any engagement in HIV risk behavior (Y/N)
time frame: One year
description: Any engagement in HIV risk behavior will be counted as Yes if a participant reports any unprotected vaginal or anal sex or reports any injection drug use that includes the sharing of injection equipment.
measure: Any criminal activity (Y/N)
time frame: One year
description: Criminal activity will counted as Yes if a participant reports any days of illegal activity in the previous 30 days, or has been arrested for any new crime in the previous 30 days according to publically available records maintained by the Maryland DPSCS.
arm group label: Therapeutic Workplace
arm group type: Experimental
description: Participants assigned to this condition will receive the standard services and requirements for diversion as described for the usual care group, and will also be eligible to attend the three-phase Therapeutic Workplace (TW) intervention. All phases of this intervention include employment-based drug abstinence reinforcement contingencies. Under these contingencies, participants can work and earn wages or wage subsidies contingent upon drug abstinence as verified by urinalysis. Phase 1 of the TW intervention is expected to increase cocaine abstinence and to prepare participants for employment. Phase 2 of the TW intervention is expected to maintain abstinence while participants are employed in an onsite model workplace. Phase 3 is designed to increase employment in community jobs and to maintain abstinence while participants are employed in offsite community workplaces.
arm group label: Diversion to treatment (Usual Care)
arm group type: Active Comparator
description: Participants in this condition will be offered the standard treatment services available in community methadone and buprenorphine programs, including medication (methadone or buprenorphine, respectively), counseling services, HIV testing, and case management. All services will be provided in the treatment clinics. There are a number of clinics within easy walking distance from the research site, and others throughout the city that are reachable by public transportation from the research site. In addition, all participants will receive referrals to the Re-Entry Center, a One-Stop Career Center tailored to the needs of offenders, at all intake and monthly assessments. As mentioned in detail above, participants will be required by the court to stay enrolled in treatment for 90 days. It is important to note that all diverted individuals will receive these services and requirements, independent of whether they agree to participate in the pilot study.
intervention type: Drug
intervention name: Methadone
description: Clinic-Based Methadone Maintenance Treatment
arm group label: Diversion to treatment (Usual Care)
arm group label: Therapeutic Workplace
intervention type: Drug
intervention name: Buprenorphine
description: Clinic-Based Buprenorphine Maintenance Treatment
arm group label: Diversion to treatment (Usual Care)
arm group label: Therapeutic Workplace
intervention type: Behavioral
intervention name: Employment-based drug abstinence reinforcement
arm group label: Therapeutic Workplace
other name: Therapeutic Workplace
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Anthony DeFulio, Ph.D.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Anthony DeFulio
investigator title: Assistant Professor
mesh term: Cocaine-Related Disorders
mesh term: Heroin Dependence
mesh term: Buprenorphine
mesh term: Methadone