Amphetamine-Related DisordersPhase 2TREXNCT01449565
Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)
A Phase 2 study testing Naltrexone in people with Amphetamine-Related Disorders, run by San Francisco Department of Public Health at 1 site in United States.
Trial summary
Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in treating alcohol dependence and prevention of relapse to opioid dependence. It has shown promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently amphetamine-abstinent heterosexuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- Naltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Mar 2016
- Phase
- Phase 2
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- born male; or born female and does not identify as female
- reports having anal sex with men in the prior six months while under the influence of meth;
- diagnosed with meth dependence as determined by SCID;
- interested in stopping or reducing meth use;
- at least one meth-positive urine during screening and run-in period;
- no current acute illnesses requiring prolonged medical care;
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- no chronic illnesses that are likely to progress clinically during trial participation;
- able and willing to provide informed consent and adhere to visit schedule;
- age 18-65 years;
- baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, total bilirubin, and electrolytes without clinically significant abnormalities as determined by investigator in conjunction with symptoms, physical exam, and medical history.
Who cannot join
- any psychiatric condition (e.g. current depression with suicidal ideation or schizophrenia) that would preclude safe participation in the protocol;
- known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluents;
- current use of or dependence on any opioids; a known medical condition which currently requires or is likely to require opioid analgesics; or positive opioid urine screening tests
- diagnosed with current alcohol dependence as determined by the SCID;
- current CD4 count < 200 cells/mm3;
- moderate or severe liver disease (AST and/or ALT > 5 times upper limit of normal);
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- moderately or severely impaired renal function (eGFR < 50 mL/min);
- thrombocytopenia or other coagulation disorder
- currently participating in another research study;
- pending legal proceedings with high risk for incarceration during the time of planned study participation;
- any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Use Research Unit
San Francisco, California, 94102
About this study
Official title: Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men
Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in treating alcohol dependence and prevention of relapse to opioid dependence. It has shown promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work to determine whether monthly intramuscular injections of naltrexone will reduce methamphetamine (meth) use among actively using, meth-dependent men who have sex with men (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus placebo. The investigators will focus on MSM because of the disproportionate and intertwining epidemics of meth use and HIV in this population.
Read the detailed description
The investigators will enroll 100 sexually active, meth-dependent MSM who will be randomized 1:1 to receive monthly injections of extended-release naltrexone (n=50) or placebo (n=50) for 12 weeks at weeks 0, 4, and 8. Study participants will be seen weekly at our site at the HIV Prevention Section of the San Francisco Department of Public Health, where they will provide urine for drug testing and participate in substance use counseling. All participants will receive HIV risk-reduction counseling. Behavior will be assessed using standardized measures via audio computer-assisted self-interview (ACASI).
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Naltrexone, Placebo
- Keywords
- methamphetamine, high-risk sexual behavior, HIV prevention
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called XR-NTX, VIVITROL
3 monthly intramuscular injections of naltrexone 380 mg (extended release)
PlaceboDrug
3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Active comparator | Not described Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine meth positivity
proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12
Measured: 12 weeks
Secondary outcomes (3)
reduction in sexual risk behavior
reduction in meth-associated sexual risk behavior as measured by: numbers of male anal sex partners, serodiscordant condomless anal sex partners, serodiscordant condomless anal sex events, serodiscordant condomless receptive anal sex partners, serodiscordant condomless receptive anal sex events, serodiscordant condomless insertive anal sex partners, serodiscordant condomless insertive anal sex events, and numbers of sex partners with whom meth was used, by study arm
Measured: 12 weeks
percentage of total expected injections administered
acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm
Measured: 12 weeks
rates of adverse events
rates of adverse events will be compared by study arm
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 posted10 Oct 2011 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine-Related DisordersStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Collaborators
- Alkermes, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
- Investigators
- Steven L. Batki, MD, Principal investigator, Substance Abuse Programs, San Francisco VA Medical CenterPhillip Coffin, MD, MIA, Principal investigator, Substance Use Research Unit, San Francisco Department of Public HealthEmily Behar, MS, Study director, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449565
- Sponsor's protocol ID
- R01DA031678
- Other IDs
- R01DA031678
- Acronym
- TREX
- Status last verified
- Apr 2016
- First submitted
- 4 Oct 2011
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT01449565
- Acronym / sponsor ID
- TREX / R01DA031678
- Conditions
- Amphetamine-Related Disorders
- Keywords
- methamphetamine, high-risk sexual behavior, HIV prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Collaborators
- Alkermes, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Oct 2011 (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.
Extended-release naltrexone (XR-NTX, VIVITROL) is an FDA-approved medication with efficacy in treating alcohol dependence and prevention of relapse to opioid dependence. It has shown promise in reducing relapse to amphetamine use among amphetamine-dependent, yet currently amphetamine-abstinent heterosexuals. The investigators will expand upon this promising work to determine whether monthly intramuscular injections of naltrexone will reduce methamphetamine (meth) use among actively using, meth-dependent men who have sex with men (MSM) in this double-blind randomized controlled trial of extended-release naltrexone versus placebo. The investigators will focus on MSM because of the disproportionate and intertwining epidemics of meth use and HIV in this population.
Detailed description
The investigators will enroll 100 sexually active, meth-dependent MSM who will be randomized 1:1 to receive monthly injections of extended-release naltrexone (n=50) or placebo (n=50) for 12 weeks at weeks 0, 4, and 8. Study participants will be seen weekly at our site at the HIV Prevention Section of the San Francisco Department of Public Health, where they will provide urine for drug testing and participate in substance use counseling. All participants will receive HIV risk-reduction counseling. Behavior will be assessed using standardized measures via audio computer-assisted self-interview (ACASI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Active comparator | Drug: Naltrexone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- born male; or born female and does not identify as female
- reports having anal sex with men in the prior six months while under the influence of meth;
- diagnosed with meth dependence as determined by SCID;
- interested in stopping or reducing meth use;
- at least one meth-positive urine during screening and run-in period;
Key exclusion criteria (11 listed)
- any psychiatric condition (e.g. current depression with suicidal ideation or schizophrenia) that would preclude safe participation in the protocol;
- known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluents;
- current use of or dependence on any opioids; a known medical condition which currently requires or is likely to require opioid analgesics; or positive opioid urine screening tests
- diagnosed with current alcohol dependence as determined by the SCID;
- current CD4 count < 200 cells/mm3;
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 |
|---|---|---|
| NaltrexoneAlso: XR-NTX, VIVITROL3 monthly intramuscular injections of naltrexone 380 mg (extended release) | Drug | Naltrexone |
| Placebo3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release) | Drug | Placebo |
Primary outcome
urine meth positivity
Time frame: 12 weeks
proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12
3 secondary outcomes
reduction in sexual risk behavior
Time frame: 12 weeks
percentage of total expected injections administered
Time frame: 12 weeks
rates of adverse events
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 13 Apr 2016.
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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.
Steven L. Batki, MD principal investigator
Substance Abuse Programs, San Francisco VA Medical Center
Phillip Coffin, MD, MIA principal investigator
Substance Use Research Unit, San Francisco Department of Public Health
Emily Behar, MS study director
San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Amphetamine-Related Disorders, run by San Francisco Department of Public Health at 1 site in United States.
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 10 inclusion and 11 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 13 Apr 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
urine meth positivity (time frame: 12 weeks). 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 13 Apr 2016.