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Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin

Primary Purpose

Cocaine-Related Disorders, HIV, Heroin Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methadone
Buprenorphine
Employment-based drug abstinence reinforcement
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine, Heroin, HIV, Contingency Management, Incentives, Criminal Justice, Methadone, Buprenorphine, Employment, Job Training, Wage Subsidies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • report using heroin at least 20 of the last 30 days of living in the community
  • meet criteria for methadone maintenance (at least one year of meeting DSM IV criteria for heroin dependence)
  • have visible track marks or other clear physical evidence of injection drug use
  • report using cocaine in the last 30 days
  • were unemployed prior to arrest
  • have a income below the federal poverty level
  • live in the Baltimore City area

Exclusion Criteria:

  • report current suicidal ideation or hallucinations
  • receiving opioid pharmacotherapy prior to arrest
  • have a serious uncontrolled medical condition that would prevent attendance in methadone or buprenorphine treatment
  • are pregnant or breastfeeding
  • have a physical imparement that would prevent typing

Sites / Locations

  • Center for Learning and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic Workplace

Diversion to treatment (Usual Care)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Cocaine abstinence as assessed by urinalysis
dichotomous (Y/N)
Cocaine abstinence as assessed by self-reports
dichotomous (Y/N)

Secondary Outcome Measures

Any drug use (Y/N)
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).
Any engagement in HIV risk behavior (Y/N)
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.
Any criminal activity (Y/N)
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.

Full Information

First Posted
November 6, 2012
Last Updated
December 10, 2014
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01723527
Brief Title
Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, HIV, Heroin Dependence
Keywords
Cocaine, Heroin, HIV, Contingency Management, Incentives, Criminal Justice, Methadone, Buprenorphine, Employment, Job Training, Wage Subsidies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Workplace
Arm Type
Experimental
Arm 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 Title
Diversion to treatment (Usual Care)
Arm Type
Active Comparator
Arm 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(s)
Methadone
Intervention Description
Clinic-Based Methadone Maintenance Treatment
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
Clinic-Based Buprenorphine Maintenance Treatment
Intervention Type
Behavioral
Intervention Name(s)
Employment-based drug abstinence reinforcement
Other Intervention Name(s)
Therapeutic Workplace
Primary Outcome Measure Information:
Title
Cocaine abstinence as assessed by urinalysis
Description
dichotomous (Y/N)
Time Frame
One year
Title
Cocaine abstinence as assessed by self-reports
Description
dichotomous (Y/N)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Any drug use (Y/N)
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).
Time Frame
One year
Title
Any engagement in HIV risk behavior (Y/N)
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.
Time Frame
One year
Title
Any criminal activity (Y/N)
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: report using heroin at least 20 of the last 30 days of living in the community meet criteria for methadone maintenance (at least one year of meeting DSM IV criteria for heroin dependence) have visible track marks or other clear physical evidence of injection drug use report using cocaine in the last 30 days were unemployed prior to arrest have a income below the federal poverty level live in the Baltimore City area Exclusion Criteria: report current suicidal ideation or hallucinations receiving opioid pharmacotherapy prior to arrest have a serious uncontrolled medical condition that would prevent attendance in methadone or buprenorphine treatment are pregnant or breastfeeding have a physical imparement that would prevent typing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony DeFulio, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Diversion to Treatment for Injection Drug Users Arrested for Possession of Heroin

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