Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution

This study is currently recruiting participants.
Verified October 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony DeFulio, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01560221
First received: March 15, 2012
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

The combination of using injection drugs, smoking crack cocaine, having multiple sex partners, and inconsistent condom use results in substantial risk for acquiring and transmitting HIV, and many drug dependent adults who have been arrested on charges of prostitution fit this profile. Existing interventions for reducing HIV risk have had limited efficacy in drug-dependent sex workers, and criminal justice approaches have been ineffective despite their high cost. A potentially ideal alternative is to divert drug-dependent arrestees from prosecution to a treatment that reduces drug use and HIV sex risk behaviors, while providing job skills training and promoting community employment to alleviate the financial need to continue sex work. In order to provide an effective therapeutic alternative to criminal prosecution, the investigators propose to develop a multifaceted intervention that includes opiate agonist treatment (i.e., methadone OR buprenorphine) and the Therapeutic Workplace. The Therapeutic Workplace is a supported environment in which participants are required to provide drug-free urine samples to access paid job skills training or employment and to maintain the maximum rate of pay. The overall intervention is designed to reduce drug use and HIV risk behaviors, and simultaneously promote employment. The proposed project is a 2-year Stage I behavior therapy development effort that will include the development, manualization and pilot testing of a Therapeutic Workplace intervention tailored to drug-dependent adults arrested for prostitution. In the pilot study, the investigators will recruit opiate- and cocaine-dependent adults arrested for prostitution from the Eastside District Court in Baltimore. Eligible individuals will be offered methadone treatment in lieu of prosecution and will be required to remain in methadone treatment for 90 days to have the charges against them dropped. After enrolling in opiate agonist treatment, the diverted individuals will be invited to participate in the pilot study. Interested individuals will be randomly assigned to receive the standard opiate agonist treatment services or these services plus the Therapeutic Workplace. The Therapeutic Workplace has two phases. In Phase 1, participants will be offered four months of stipend-supported job training in the Therapeutic Workplace. In Phase 2, participants will be encouraged to seek employment in a community job and will receive wage subsidies for four months for maintaining community employment or engaging in supervised job seeking. Throughout both phases, participants will be required to provide drug-free urine samples to receive Therapeutic Workplace wages (training stipends in Phase 1 and wage subsidies in Phase 2). The wage subsidy program will include drug testing managed by a national supplier of drug-free workplace services. Overall, this treatment could serve as a novel and ideal intervention for drug-dependent adults arrested for prostitution while reducing criminal justice costs.


Condition Intervention Phase
Substance-related Disorders
HIV Risk Behavior
Behavioral: Therapeutic Workplace
Drug: Methadone
Drug: Buprenorphine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Drug abstinence [ Time Frame: Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period. ] [ Designated as safety issue: No ]
    A combination of urinalysis and self-reports of illicit drug use. This outcome is treated as dichotomous: Urine samples are considered positive or negative based on standard cutoffs for drugs of abuse, and self-reports are yes or no depending upon whether there was or was not any drug use in the previous 30 days.


Secondary Outcome Measures:
  • HIV Sex Risk [ Time Frame: Participants will be followed for eight months. HIV Sex Risk will be measured every 30 days throughout the eight month period. ] [ Designated as safety issue: No ]
    The self-reported number of unprotected vaginal and anal sex occasions in the prior month.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic Workplace
Participants will receive all standard services plus the Therapeutic Workplace intervention, in which access to stipend supported training and/or wage subsidies for community employment is contingent upon drug abstinence as verified by urinalysis.
Behavioral: Therapeutic Workplace
Participants can access stipend supported academic and job skills training for adults and/or receive wages or wage subsides for actual employment. Access to training and employment is contingent upon meeting therapeutic targets. Potential targets include, but are not limited to, drug abstinence and medication adherence.
Drug: Methadone
Methadone in liquid form, with the dosage determined by physician on an individual basis. Anticipated dose range 30mg to 100mg daily. Methadone is administered daily at a methadone clinic for as long as enrollment in the methadone clinic is maintained.
Drug: Buprenorphine
Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence. Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
Other Name: Suboxone, Subutex
Active Comparator: Standard Services
Participants will receive methadone treatment or buprenorphine treatment, depending upon medical recommendations of their physicians, slot availability, and their own preferences. Participants who remain in treatment for at least 90 days will have the charge of prostitution that is pending against them dropped.
Drug: Methadone
Methadone in liquid form, with the dosage determined by physician on an individual basis. Anticipated dose range 30mg to 100mg daily. Methadone is administered daily at a methadone clinic for as long as enrollment in the methadone clinic is maintained.
Drug: Buprenorphine
Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence. Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
Other Name: Suboxone, Subutex

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Opioid dependent
  • Adults
  • Recently arrested
  • Have a pending charge of prostitution or perverted practice
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560221

Contacts
Contact: Jeanne Harrison, M.S. 410-550-6723 jeanne@jhmi.edu

Locations
United States, Maryland
The Center for Learning and Health Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jeanne Harrison, M.S.    410-550-6723    jeanne@jhmi.edu   
Principal Investigator: Anthony DeFulio, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Anthony DeFulio, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Anthony DeFulio, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01560221     History of Changes
Other Study ID Numbers: R34DA033141
Study First Received: March 15, 2012
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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 April 21, 2014