Opioid DependencePhase 4NCT00763958
Relapse Prevention to Reduce HIV Among Women Prisoners
A Phase 4 study testing Buprenorphine in people with Opioid Dependence and HIV, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, HIV
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female,
- history of opioid dependence,
- released back to the community from a controlled environment,
- criminal justice involvement.
Who cannot join
- under age 19,
- medical contraindications,
- major psychiatric problems.
About this study
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.
Read the 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.
- Conditions
- Opioid Dependence, HIV
- Being tested
- Placebo, Buprenorphine
- Keywords
- opiates, HIV
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo to match buprenorphine administered for 3 months
BuprenorphineDrug
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months Receives: Drug: Buprenorphine |
| Placebo | Placebo comparator | Placebo sublingual medication provided to individuals randomized to control up to 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 24 weeks
Secondary outcomes (1)
Number of Participants Who Enroll in the Study.
To determine the number of participants who enroll in the study during the time of recruitment.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Karen Cropsey, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763958
- Sponsor's protocol ID
- R21DA019838
- Other IDs
- 5R21DA019838-03, 7R21DA019838-02
- Status last verified
- May 2012
- First submitted
- 29 Sep 2008
- Last updated
- 4 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse Prevention to Reduce HIV Among Women Prisoners
- ClinicalTrials.gov ID
- NCT00763958
- Acronym / sponsor ID
- R21DA019838
- Conditions
- Opioid Dependence, HIV
- Keywords
- opiates, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Posted 4 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: BuprenorphineActive sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo sublingual medication provided to individuals randomized to control up to 3 months |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female,
- history of opioid dependence,
- released back to the community from a controlled environment,
- criminal justice involvement.
Key exclusion criteria (3 listed)
- under age 19,
- medical contraindications,
- major psychiatric problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo to match buprenorphine administered for 3 months | Drug | Placebo |
| BuprenorphineBuprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily. | Drug | Buprenorphine |
Primary outcome
Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
Time frame: 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.
Time frame: 24 weeks
Number of participants with positive opiate urine sample at the 24 week follow-up.
1 secondary outcome
Number of Participants Who Enroll in the Study.
Time frame: up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine in people with Opioid Dependence and HIV, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.