Relapse Prevention to Reduce HIV Among Women Prisoners

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00763958
First received: September 29, 2008
Last updated: May 1, 2012
Last verified: May 2012

September 29, 2008
May 1, 2012
May 2008
September 2009   (final data collection date for primary outcome measure)
  • Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants with positive opiate urine samples at 12 weeks of treatment.
  • Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Number of participants with positive opiate urine sample at the 24 week follow-up.
acceptability and feasibility [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00763958 on ClinicalTrials.gov Archive Site
Number of Participants Who Enroll in the Study. [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
To determine the number of participants who enroll in the study during the time of recruitment.
Not Provided
Not Provided
Not Provided
 
Relapse Prevention to Reduce HIV Among Women Prisoners
Relapse Prevention to Reduce HIV Among Women Prisoners

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Opioid Dependence
  • HIV
  • Drug: Placebo
    Placebo to match buprenorphine administered for 3 months
  • Drug: Buprenorphine
    Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
  • Experimental: Buprenorphine
    Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months
    Intervention: Drug: Buprenorphine
  • Placebo Comparator: Placebo
    Placebo sublingual medication provided to individuals randomized to control up to 3 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2010
September 2009   (final data collection date for primary outcome measure)

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.
Female
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00763958
R21DA019838, 5R21DA019838-03, 7R21DA019838-02
Yes
Karen Cropsey, University of Alabama at Birmingham
University of Alabama at Birmingham
National Institute on Drug Abuse (NIDA)
Not Provided
University of Alabama at Birmingham
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP