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Relapse Prevention to Reduce HIV Among Women Prisoners

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
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
History of Changes
  Purpose

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 Intervention Phase
Opioid Dependence
HIV
 Drug: Placebo
Drug: Buprenorphine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Relapse Prevention to Reduce HIV Among Women Prisoners

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Karen Cropsey, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00763958     History of Changes
Other Study ID Numbers: R21DA019838, 5R21DA019838-03, 7R21DA019838-02
Study First Received: September 29, 2008
Results First Received: February 4, 2011
Last Updated: May 1, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
opiates
HIV

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
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

ClinicalTrials.gov processed this record on May 19, 2013