Trial Outcomes & Findings for Relapse Prevention to Reduce HIV Among Women Prisoners (NCT NCT00763958)

Results Overview

Number of participants with positive opiate urine samples at 12 weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-06-04

Participant Flow

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.

Initially, 11 women were enrolled in the open-label trial, followed by 33 women randomized to either buprenorphine or placebo.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	28	16
Overall Study COMPLETED	14	5
Overall Study NOT COMPLETED	14	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study did not meet final criteria	4	4
Overall Study Lost to Follow-up	10	2
Overall Study Believed they were receiving placebo	0	5

Baseline Characteristics

Relapse Prevention to Reduce HIV Among Women Prisoners

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine n=28 Participants Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.	Placebo n=16 Participants Medication "sugar pill" provided for 12 weeks up to 32 mg daily.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	30.2 years STANDARD_DEVIATION 6.6 • n=5 Participants	34.7 years STANDARD_DEVIATION 10.3 • n=7 Participants	31.8 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All subjects were included in the analysis population as intent to treat.

Number of participants with positive opiate urine samples at 12 weeks of treatment.

Outcome measures

Outcome measures
Measure	Buprenorphine n=24 Participants Buprenorphine provided for 12 weeks of study drug based on clinical assessment.	Placebo n=12 Participants Medication "sugar pill" provided for 12 weeks.
Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.	14 participants	5 participants

PRIMARY outcome

Timeframe: 24 weeks

Population: All subjects were included in the analysis population as intent to treat.

Number of participants with positive opiate urine sample at the 24 week follow-up.

Outcome measures

Outcome measures
Measure	Buprenorphine n=24 Participants Buprenorphine provided for 12 weeks of study drug based on clinical assessment.	Placebo n=12 Participants Medication "sugar pill" provided for 12 weeks.
Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.	4 participants	4 participants

SECONDARY outcome

Timeframe: up to 24 months

To determine the number of participants who enroll in the study during the time of recruitment.

Outcome measures

Outcome measures
Measure	Buprenorphine n=28 Participants Buprenorphine provided for 12 weeks of study drug based on clinical assessment.	Placebo n=16 Participants Medication "sugar pill" provided for 12 weeks.
Number of Participants Who Enroll in the Study.	28 participants	16 participants

Adverse Events

Buprenorphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karen Cropsey

University of Alabama at Birmingham

Phone: 205-917-3786

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place