HIVPhase 3NCT01131273
HIV Risk Reduction in Subutex Injectors in Tbilisi
A Phase 3 study testing methadone and buprenorphine-naloxone (Suboxone) for 12 weeks in people with HIV, run by University of Pennsylvania at 1 site in Georgia.
Trial summary
This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- methadone and buprenorphine-naloxone (Suboxone) for 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGeorgia
- Study dates
- Jun 2010to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current opioid dependence;
- injecting buprenorphine 10 or more times in the last 30 days;
- between 25 and 50 years of age;
- buprenorphine and/or opiate positive urine test;
- not on methadone maintenance in last 4 weeks;
- stable address within Tbilisi and not planning to move;
Show all 9Show fewer
- home or cellular phone number where can be reached;
- able to provide name of family member who knows whereabouts;
- willingness and ability to give informed consent.
Who cannot join
- currently dependent on alcohol, benzodiazepines or other CNS depressants;
- legan charges with impending incarceration;
- plans to move from Tbilisi within next 6 months;
- current participation in another treatment study;
- serious medical problems that would impair or make hazardous ability to participate;
- active TB;
- currently psychotic/suicidal;
- uncontrolled seizure disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors
This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative of Georgia in Tbilisi.
- Conditions
- HIV
- Being tested
- methadone, buprenorphine-naloxone (Suboxone) for 12 weeks
- Keywords
- buprenorphine injecting, opiate dependence, HIV risk, treatment outcome, opiate dependence with buprenorphine injecting
- 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.
methadoneDrug
12 weeks of methadone maintenance with counseling
buprenorphine-naloxone (Suboxone) for 12 weeksDrug
12 weeks of maintenance with counseling
| Study group | Role | What they receive |
|---|---|---|
| Methadone maintenance for 12 weeks | Active comparator | Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone. Receives: Drug: methadone |
| buprenorphine-naloxone (Suboxone) | Active comparator | 12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling Receives: Drug: buprenorphine-naloxone (Suboxone) for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buprenorphine injecting
- Obtain pilot data on the impact of a 12-week course of daily, observed Suboxone and methadone treatment on HIV injecting risk behavior, particularly that associated with injecting use of Subutex. 2) obtain pilot data on the degree to which the target population accepts treatment with daily observed Suboxone and methadone.
Measured: 12 weeks
Secondary outcomes (1)
HIV Risk
Obtain pilot data on the degree to which a 12-week course of suboxone or methadone reduces illegal activities and improves employment, psychiatric symptoms, overall adjustment and assess the prevalence of HIV, HEP B/C among study patients at week 20.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Geroge Woody, MD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131273
- Sponsor's protocol ID
- RDA026754A
- Other IDs
- R21DA026754, DPMC
- Status last verified
- Aug 2016
- First submitted
- 8 Apr 2010
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Otiashvili D, Piralishvili G, Sikharulidze Z, Kamkamidze G, Poole S, Woody GE. Methadone and buprenorphine-naloxone are effective in reducing illicit buprenorphine and other opioid use, and reducing HIV risk behavior--outcomes of a randomized trial. Drug Alcohol Depend. 2013 Dec 1;133(2):376-82. doi: 10.1016/j.drugalcdep.2013.06.024. Epub 2013 Jul 31.
PubMed 23916321
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors
- ClinicalTrials.gov ID
- NCT01131273
- Acronym / sponsor ID
- RDA026754A
- Conditions
- HIV
- Keywords
- buprenorphine injecting, opiate dependence, HIV risk, treatment outcome, opiate dependence with buprenorphine injecting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative of Georgia in Tbilisi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone maintenance for 12 weeks | Active comparator | Drug: methadoneMethadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone. |
| buprenorphine-naloxone (Suboxone) | Active comparator | Drug: buprenorphine-naloxone (Suboxone) for 12 weeks12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- current opioid dependence;
- injecting buprenorphine 10 or more times in the last 30 days;
- between 25 and 50 years of age;
- buprenorphine and/or opiate positive urine test;
- not on methadone maintenance in last 4 weeks;
Key exclusion criteria (8 listed)
- currently dependent on alcohol, benzodiazepines or other CNS depressants;
- legan charges with impending incarceration;
- plans to move from Tbilisi within next 6 months;
- current participation in another treatment study;
- serious medical problems that would impair or make hazardous ability to participate;
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 |
|---|---|---|
| methadone12 weeks of methadone maintenance with counseling | Drug | Methadone maintenance for 12 weeks |
| buprenorphine-naloxone (Suboxone) for 12 weeks12 weeks of maintenance with counseling | Drug | buprenorphine-naloxone (Suboxone) |
Primary outcome
Buprenorphine injecting
Time frame: 12 weeks
1) Obtain pilot data on the impact of a 12-week course of daily, observed Suboxone and methadone treatment on HIV injecting risk behavior, particularly that associated with injecting use of Subutex. 2) obtain pilot data on the degree to which the target population accepts treatment with daily observed Suboxone and methadone.
1 secondary outcome
HIV Risk
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Derived from this study: PubMed 23916321Otiashvili D, Piralishvili G, Sikharulidze Z, Kamkamidze G, Poole S, Woody GE. Methadone and buprenorphine-naloxone are effective in reducing illicit buprenorphine and other opioid use, and reducing HIV risk behavior--outcomes of a randomized trial. Drug Alcohol Depend. 2013 Dec 1;133(2):376-82. doi: 10.1016/j.drugalcdep.2013.06.024. Epub 2013 Jul 31.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Geroge Woody, MD study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methadone and buprenorphine-naloxone (Suboxone) for 12 weeks in people with HIV, run by University of Pennsylvania at 1 site in Georgia.
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 9 inclusion and 8 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Buprenorphine injecting (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01131273, which also lists 1 linked publication.
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 19 Aug 2016.