Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution
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ClinicalTrials.gov Identifier: NCT01560221 |
Recruitment Status
:
Completed
First Posted
: March 22, 2012
Last Update Posted
: December 11, 2014
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Condition or disease | Intervention/treatment | Phase |
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Substance-related Disorders HIV Risk Behavior | Behavioral: Therapeutic Workplace Drug: Methadone Drug: Buprenorphine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Reducing Drug Use and HIV Risk in Drug-dependent Adults Arrested for Prostitution |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
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.
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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
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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.
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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
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- Drug abstinence [ Time Frame: Participants will be followed for eight months. Drug abstinence will be measured every 30 days throughout the eight month period. ]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.
- 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. ]The self-reported number of unprotected vaginal and anal sex occasions in the prior month.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Opioid dependent
- Adults
- Recently arrested
- Have a pending charge of prostitution or perverted practice

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560221
United States, Maryland | |
The Center for Learning and Health | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Anthony DeFulio, Ph.D. | Johns Hopkins University |
Responsible Party: | Anthony DeFulio, Assistant Professor, Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01560221 History of Changes |
Other Study ID Numbers: |
R34DA033141 ( U.S. NIH Grant/Contract ) |
First Posted: | March 22, 2012 Key Record Dates |
Last Update Posted: | December 11, 2014 |
Last Verified: | December 2014 |
Additional relevant MeSH terms:
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Methadone Buprenorphine, Naloxone Drug Combination Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Antitussive Agents Respiratory System Agents |