Trial record 5 of 15 for:    Open Studies | "Heroin Dependence"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony DeFulio, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01723527
First received: November 6, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cocaine-Related Disorders
HIV
Heroin Dependence
Drug: Methadone
Drug: Buprenorphine
Behavioral: Employment-based drug abstinence reinforcement
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cocaine abstinence as assessed by urinalysis [ Time Frame: One year ] [ Designated as safety issue: No ]
    dichotomous (Y/N)

  • Cocaine abstinence as assessed by self-reports [ Time Frame: One year ] [ Designated as safety issue: No ]
    dichotomous (Y/N)


Secondary Outcome Measures:
  • Any drug use (Y/N) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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) [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic Workplace
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.
Drug: Methadone
Clinic-Based Methadone Maintenance Treatment
Drug: Buprenorphine
Clinic-Based Buprenorphine Maintenance Treatment
Behavioral: Employment-based drug abstinence reinforcement
Other Name: Therapeutic Workplace
Active Comparator: Diversion to treatment (Usual Care)
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.
Drug: Methadone
Clinic-Based Methadone Maintenance Treatment
Drug: Buprenorphine
Clinic-Based Buprenorphine Maintenance Treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723527

Contacts
Contact: Jeanne Harrison, M.A. 410-550-6723 jeanne@jhmi.edu
Contact: Anthony DeFulio, Ph.D. 410-550-9935 defulio@jhmi.edu

Locations
United States, Maryland
Center for Learning and Health Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Jeanne Harrison, M.A.    410-550-6723    jeanne@jhmi.edu   
Contact: Jacqueline Hampton    410-550-7713    jhampton@jhmi.edu   
Principal Investigator: Anthony DeFulio, Ph.D.         
Sub-Investigator: Kenneth Silverman, Ph.D.         
Sub-Investigator: Michael Fingerhood, M.D.         
Sub-Investigator: George Bigelow, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Anthony DeFulio, Ph.D. Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Anthony DeFulio, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01723527     History of Changes
Other Study ID Numbers: 1R34DA033510-01
Study First Received: November 6, 2012
Last Updated: November 6, 2012
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Cocaine
Heroin
HIV
Contingency Management
Incentives
Criminal Justice
Methadone
Buprenorphine
Employment
Job Training
Wage Subsidies

Additional relevant MeSH terms:
Heroin Dependence
Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 20, 2014