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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Opioid Dependence
HIV
Interventions Drug: Placebo
Drug: Buprenorphine
Enrollment 44
Recruitment Details Recruitment began in May of 2008 and ended June of 2010. All participants were recruited from a 28-day drug inpatient facility that accepts patients from the criminal justice system.
Pre-assignment Details Initially, 11 women were enrolled in the open-label trial, followed by 33 women randomized to either buprenorphine or placebo.
Arm/Group Title Buprenorphine Placebo
Hide Arm/Group Description Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment. Medication "sugar pill" provided for 12 weeks up to 32 mg daily.
Period Title: Overall Study
Started 28 16
Completed 14 5
Not Completed 14 11
Reason Not Completed
did not meet final criteria             4             4
Lost to Follow-up             10             2
Believed they were receiving placebo             0             5
Arm/Group Title Buprenorphine Placebo Total
Hide Arm/Group Description Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment. Medication "sugar pill" provided for 12 weeks up to 32 mg daily. Total of all reporting groups
Overall Number of Baseline Participants 28 16 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
16
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 16 participants 44 participants
30.2  (6.6) 34.7  (10.3) 31.8  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 16 participants 44 participants
Female
28
 100.0%
16
 100.0%
44
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
Hide Description Number of participants with positive opiate urine samples at 12 weeks of treatment.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects were included in the analysis population as intent to treat.
Arm/Group Title Buprenorphine Placebo
Hide Arm/Group Description:
Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
Medication "sugar pill" provided for 12 weeks.
Overall Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: participants
14 5
2.Primary Outcome
Title Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.
Hide Description Number of participants with positive opiate urine sample at the 24 week follow-up.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects were included in the analysis population as intent to treat.
Arm/Group Title Buprenorphine Placebo
Hide Arm/Group Description:
Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
Medication "sugar pill" provided for 12 weeks.
Overall Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: participants
4 4
3.Secondary Outcome
Title Number of Participants Who Enroll in the Study.
Hide Description To determine the number of participants who enroll in the study during the time of recruitment.
Time Frame up to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine Placebo
Hide Arm/Group Description:
Buprenorphine provided for 12 weeks of stuty drug based on clinical assessment.
Medication "sugar pill" provided for 12 weeks.
Overall Number of Participants Analyzed 28 16
Measure Type: Number
Unit of Measure: participants
28 16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine Placebo
Hide Arm/Group Description Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment. Medication "sugar pill" provided for 12 weeks up to 32 mg daily.
All-Cause Mortality
Buprenorphine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Buprenorphine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/16 (0.00%) 
Slow recruitment with poor retention. Transient population that was difficult to effectively track.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Karen Cropsey
Organization: University of Alabama at Birmingham
Phone: 205-917-3786 ext 205
Responsible Party: Karen Cropsey, 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