HIV, Opioid Dependence
Conditions
Keywords
opiates, HIV
Brief summary
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.
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.
Interventions
DRUGPlacebo
Placebo to match buprenorphine administered for 3 months
DRUGBuprenorphine
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. | 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. | 24 weeks | Number of participants with positive opiate urine sample at the 24 week follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Enroll in the Study. | up to 24 months | To determine the number of participants who enroll in the study during the time of recruitment. |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Buprenorphine Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment. | 28 |
| Placebo Medication sugar pill provided for 12 weeks up to 32 mg daily. | 16 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Believed they were receiving placebo | 0 | 5 |
| Overall Study | did not meet final criteria | 4 | 4 |
| Overall Study | Lost to Follow-up | 10 | 2 |
Baseline characteristics
| Characteristic | Buprenorphine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 16 Participants | 44 Participants |
| Age Continuous | 30.2 years STANDARD_DEVIATION 6.6 | 34.7 years STANDARD_DEVIATION 10.3 | 31.8 years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 28 Participants | 16 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 16 |
| serious Total, serious adverse events | 0 / 28 | 0 / 16 |
Outcome results
Primary
Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
Number of participants with positive opiate urine samples at 12 weeks of treatment.
Time frame: 12 weeks
Population: All subjects were included in the analysis population as intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buprenorphine | Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. | 14 participants |
| Placebo | Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. | 5 participants |
Primary
Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.
Number of participants with positive opiate urine sample at the 24 week follow-up.
Time frame: 24 weeks
Population: All subjects were included in the analysis population as intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buprenorphine | Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. | 4 participants |
| Placebo | Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. | 4 participants |
Secondary
Number of Participants Who Enroll in the Study.
To determine the number of participants who enroll in the study during the time of recruitment.
Time frame: up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buprenorphine | Number of Participants Who Enroll in the Study. | 28 participants |
| Placebo | Number of Participants Who Enroll in the Study. | 16 participants |