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Relapse Prevention to Reduce HIV Among Women Prisoners

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ClinicalTrials.gov Identifier: NCT00763958
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : June 4, 2012
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.

Condition or disease Intervention/treatment Phase
Opioid Dependence HIV Drug: Placebo Drug: Buprenorphine Phase 4

Detailed Description:
This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenorphine medication. After the first 9 participants, women were randomized to either buprenorphine or placebo. Women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. One additional follow-up at 3 months after treatment was conducted. The primary outcome was opioid positive urines at all time points.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Relapse Prevention to Reduce HIV Among Women Prisoners
Study Start Date : May 2008
Primary Completion Date : September 2009
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Buprenorphine
Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months
Drug: Buprenorphine
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
Placebo Comparator: Placebo
Placebo sublingual medication provided to individuals randomized to control up to 3 months
Drug: Placebo
Placebo to match buprenorphine administered for 3 months

Outcome Measures

Primary Outcome Measures :
  1. Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. [ Time Frame: 12 weeks ]
    Number of participants with positive opiate urine samples at 12 weeks of treatment.

  2. Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. [ Time Frame: 24 weeks ]
    Number of participants with positive opiate urine sample at the 24 week follow-up.

Secondary Outcome Measures :
  1. Number of Participants Who Enroll in the Study. [ Time Frame: up to 24 months ]
    To determine the number of participants who enroll in the study during the time of recruitment.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • female,
  • history of opioid dependence,
  • released back to the community from a controlled environment,
  • criminal justice involvement.

Exclusion Criteria:

  • under age 19,
  • medical contraindications,
  • major psychiatric problems.
More Information

Responsible Party: Karen Cropsey, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00763958     History of Changes
Other Study ID Numbers: R21DA019838 ( U.S. NIH Grant/Contract )
5R21DA019838-03 ( U.S. NIH Grant/Contract )
7R21DA019838-02 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2008    Key Record Dates
Results First Posted: June 4, 2012
Last Update Posted: June 4, 2012
Last Verified: May 2012

Keywords provided by Karen Cropsey, University of Alabama at Birmingham:

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists