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
Results First Received: February 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Opioid Dependence
HIV
Interventions: Drug: Placebo
Drug: Buprenorphine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Initially, 11 women were enrolled in the open-label trial, followed by 33 women randomized to either buprenorphine or placebo.

Reporting Groups
  Description
Buprenorphine Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
Placebo Medication "sugar pill" provided for 12 weeks up to 32 mg daily.

Participant Flow:   Overall Study
    Buprenorphine     Placebo  
STARTED     28     16  
COMPLETED     14     5  
NOT COMPLETED     14     11  
did not meet final criteria                 4                 4  
Lost to Follow-up                 10                 2  
Believed they were receiving placebo                 0                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Buprenorphine Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
Placebo Medication "sugar pill" provided for 12 weeks up to 32 mg daily.
Total Total of all reporting groups

Baseline Measures
    Buprenorphine     Placebo     Total  
Number of Participants  
[units: participants]
  28     16     44  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     16     44  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.2  ± 6.6     34.7  ± 10.3     31.8  ± 8.3  
Gender  
[units: participants]
     
Female     28     16     44  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.   [ Time Frame: 12 weeks ]

2.  Primary:   Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.   [ Time Frame: 24 weeks ]

3.  Secondary:   Number of Participants Who Enroll in the Study.   [ Time Frame: up to 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Slow recruitment with poor retention. Transient population that was difficult to effectively track.


  More Information
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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
e-mail: kcropsey@uab.edu


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
Results First Received: February 4, 2011
Last Updated: May 1, 2012
Health Authority: United States: Federal Government