We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Relapse Prevention to Reduce HIV Among Women Prisoners

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763958
First Posted: October 1, 2008
Last Update Posted: June 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham
  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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Relapse Prevention to Reduce HIV Among Women Prisoners

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes 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

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 Submitted: September 29, 2008
First Posted: October 1, 2008
Results First Submitted: February 4, 2011
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:
opiates
HIV

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