<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/NCT03278496</url>
  </required_header>
  <id_info>
    <org_study_id>DA13003</org_study_id>
    <nct_id>NCT03278496</nct_id>
  </id_info>
  <brief_title>Recovery Housing and Drug Abuse Treatment Outcome</brief_title>
  <official_title>Recovery Housing and Drug Abuse Treatment Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that&#xD;
      includes relapse prevention skills training, goal setting, help with finding employment and&#xD;
      abstinence-contingent rent payment for recovery housing in the community. It is meant to&#xD;
      provide motivation for continued abstinence while enhancing social stability. In this study,&#xD;
      treatment was offered to inner city opiate and cocaine users immediately following a brief&#xD;
      medically-supported residential detoxification. Previous research had shown that RBT produces&#xD;
      3- month outcomes superior to those for patients who are referred to outpatient treatment in&#xD;
      the community. The present study compared outcomes for patients (N = 243) randomly assigned&#xD;
      to receive abstinence-contingent recovery housing with (full RBT) or without additional&#xD;
      intensive counseling or to receive usual care referral to outpatient treatment following&#xD;
      detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received&#xD;
      recovery housing with (full RBT) and without additional counseling and both these treatments&#xD;
      were superior to usual care referral. Study findings support the efficacy of&#xD;
      post-detoxification recovery housing with or without counseling for opiate and cocaine users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims To conduct a randomized, controlled trial of abstinence-contingent recovery housing&#xD;
      delivered with or without intensive day treatment among individuals exiting residential&#xD;
      opioid detoxification.&#xD;
&#xD;
      Design Random assignment to one of three conditions: recovery housing alone (RH),&#xD;
      abstinence-contingent recovery housing with reinforcement-based treatment RBT (RH + RBT) or&#xD;
      usual care (UC). RH and RH + RBT participants received 12 weeks of paid recovery housing&#xD;
      contingent upon drug abstinence. RH + RBT participants also received 26 weeks of RBT,&#xD;
      initiated concurrently with recovery housing. Assessments were conducted at 1, 3 and 6 months&#xD;
      after treatment enrollment.&#xD;
&#xD;
      Setting Out-patient drug-free substance abuse treatment program in Baltimore, Maryland.&#xD;
&#xD;
      Participants Patients (n = 243) who completed medication-assisted opioid detoxification.&#xD;
&#xD;
      Measurements Primary outcome was drug abstinence (opioid- and cocaine-negative urine and no&#xD;
      self-reported opioid or cocaine use in the previous 30 days). Secondary outcomes included&#xD;
      abstinence at all time-points (1, 3 and 6 months), days in recovery housing and employment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2001</start_date>
  <completion_date type="Actual">December 2008</completion_date>
  <primary_completion_date type="Actual">June 2008</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>abstinence from opiates and cocaine</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>Free in the community plus self report of no drug use in past 30 days verified with negative urine screen.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">243</enrollment>
  <condition>Mental and Behavioral Disorders Due to Use of Cocaine: Harmful Use</condition>
  <condition>Opiate Addiction</condition>
  <arm_group>
    <arm_group_label>Recovery housing plus counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive counseling in a 5-day per week program plus abstinence-contingent rent payment in a community recovery house. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recovery Housing only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abstinence-contingent payment for recovery housing rent in absence of any formal counseling. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Referral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive referral resources for community substance abuse counseling and recovery housing but no formal treatment or help with rent payments. All participate in follow-up data collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recovery Housing plus Counseling</intervention_name>
    <description>Participants receive 3 months of abstinence-contingent program-supported rent payment in community recovery housing. They also receive intensive outpatient counseling (both individual and group) focused on relapse prevention skills training, goal setting, employment seeking and recreational activities.</description>
    <arm_group_label>Recovery housing plus counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care Referral</intervention_name>
    <description>Participants are referred to an outpatient program of their choosing with an appointment made for them.</description>
    <arm_group_label>Usual Care Referral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recovery Housing Only</intervention_name>
    <description>Participant may receive up to 3 months of abstinence-contingent rent payment in community recovery housing but is not invited to participate in intensive counseling.</description>
    <arm_group_label>Recovery Housing only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  completes residential detoxification for use of opiates and/or cocaine&#xD;
&#xD;
          -  willing to go to outpatient aftercare&#xD;
&#xD;
          -  agrees to random assignment; signs informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moving out of town&#xD;
&#xD;
          -  primary substance use does not include opiates or cocaine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maxine Stitzer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Behavioral Pharmacology Research Unit</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>
  <results_reference>
    <citation>Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28.</citation>
    <PMID>22151478</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>addiction</keyword>
  <keyword>substance abuse treatment</keyword>
  <keyword>aftercare</keyword>
  <keyword>outpatient counseling</keyword>
  <keyword>opiates</keyword>
  <keyword>cocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_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/NCT03278496
org study id: DA13003
nct id: NCT03278496
lead sponsor: 
has dmc: Yes
Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that
      includes relapse prevention skills training, goal setting, help with finding employment and
      abstinence-contingent rent payment for recovery housing in the community. It is meant to
      provide motivation for continued abstinence while enhancing social stability. In this study,
      treatment was offered to inner city opiate and cocaine users immediately following a brief
      medically-supported residential detoxification. Previous research had shown that RBT produces
      3- month outcomes superior to those for patients who are referred to outpatient treatment in
      the community. The present study compared outcomes for patients (N = 243) randomly assigned
      to receive abstinence-contingent recovery housing with (full RBT) or without additional
      intensive counseling or to receive usual care referral to outpatient treatment following
      detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received
      recovery housing with (full RBT) and without additional counseling and both these treatments
      were superior to usual care referral. Study findings support the efficacy of
      post-detoxification recovery housing with or without counseling for opiate and cocaine users.
Aims To conduct a randomized, controlled trial of abstinence-contingent recovery housing
      delivered with or without intensive day treatment among individuals exiting residential
      opioid detoxification.

      Design Random assignment to one of three conditions: recovery housing alone (RH),
      abstinence-contingent recovery housing with reinforcement-based treatment RBT (RH + RBT) or
      usual care (UC). RH and RH + RBT participants received 12 weeks of paid recovery housing
      contingent upon drug abstinence. RH + RBT participants also received 26 weeks of RBT,
      initiated concurrently with recovery housing. Assessments were conducted at 1, 3 and 6 months
      after treatment enrollment.

      Setting Out-patient drug-free substance abuse treatment program in Baltimore, Maryland.

      Participants Patients (n = 243) who completed medication-assisted opioid detoxification.

      Measurements Primary outcome was drug abstinence (opioid- and cocaine-negative urine and no
      self-reported opioid or cocaine use in the previous 30 days). Secondary outcomes included
      abstinence at all time-points (1, 3 and 6 months), days in recovery housing and employment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: abstinence from opiates and cocaine
time frame: 6 months post randomization
description: Free in the community plus self report of no drug use in past 30 days verified with negative urine screen.
arm group label: Recovery housing plus counseling
arm group type: Experimental
description: Intensive counseling in a 5-day per week program plus abstinence-contingent rent payment in a community recovery house. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry.
arm group label: Recovery Housing only
arm group type: Experimental
description: Abstinence-contingent payment for recovery housing rent in absence of any formal counseling. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry.
arm group label: Usual Care Referral
arm group type: Active Comparator
description: Participants receive referral resources for community substance abuse counseling and recovery housing but no formal treatment or help with rent payments. All participate in follow-up data collection.
intervention type: Behavioral
intervention name: Recovery Housing plus Counseling
description: Participants receive 3 months of abstinence-contingent program-supported rent payment in community recovery housing. They also receive intensive outpatient counseling (both individual and group) focused on relapse prevention skills training, goal setting, employment seeking and recreational activities.
arm group label: Recovery housing plus counseling
intervention type: Behavioral
intervention name: Usual Care Referral
description: Participants are referred to an outpatient program of their choosing with an appointment made for them.
arm group label: Usual Care Referral
intervention type: Behavioral
intervention name: Recovery Housing Only
description: Participant may receive up to 3 months of abstinence-contingent rent payment in community recovery housing but is not invited to participate in intensive counseling.
arm group label: Recovery Housing only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Maxine Stitzer, Ph.D.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
citation: Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28.
PMID: 22151478
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Opioid-Related Disorders
mesh term: Behavior, Addictive