Relapse Prevention to Reduce HIV Among Women Prisoners

This study has been completed.

First Received on September 29, 2008. Last Updated on November 22, 2010 History of Changes

Sponsor:	University of Alabama at Birmingham
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00763958

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 prevention opioid relapse.

Condition	Intervention	Phase
Opioid Relapse	Drug: Suboxone	Phase IV

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

Primary Outcome Measures:

acceptability and feasibility [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2006
Study Completion Date:	September 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Suboxone	Drug: Suboxone 8 mg of Suboxone sublingually daily for 3 months
Placebo Comparator: Placebo	Drug: Suboxone 8 mg of Suboxone sublingually daily for 3 months

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age 19 or older, no medical contraindications, no major psychiatric problems

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Karen Cropsey, 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
Last Updated:	November 22, 2010
Health Authority:	United States: Federal Government

Keywords provided by University of Alabama at Birmingham:

opiates

Additional relevant MeSH terms:

Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012