Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM) (TREX)
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ClinicalTrials.gov Identifier: NCT01449565 |
Recruitment Status
:
Completed
First Posted
: October 10, 2011
Last Update Posted
: April 13, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amphetamine-Related Disorders | Drug: Naltrexone Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Naltrexone |
Drug: Naltrexone
3 monthly intramuscular injections of naltrexone 380 mg (extended release)
Other Names:
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Placebo Comparator: Placebo |
Drug: Placebo
3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)
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- urine meth positivity [ Time Frame: 12 weeks ]proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12
- reduction in sexual risk behavior [ Time Frame: 12 weeks ]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
- percentage of total expected injections administered [ Time Frame: 12 weeks ]acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm
- rates of adverse events [ Time Frame: 12 weeks ]rates of adverse events will be compared by study arm

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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;
- 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.
Exclusion criteria:
- 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);
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449565
United States, California | |
Substance Use Research Unit | |
San Francisco, California, United States, 94102 |
Principal Investigator: | Steven L. Batki, MD | Substance Abuse Programs, San Francisco VA Medical Center | |
Principal Investigator: | Phillip Coffin, MD, MIA | Substance Use Research Unit, San Francisco Department of Public Health | |
Study Director: | Emily Behar, MS | San Francisco Department of Public Health |
Responsible Party: | Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health |
ClinicalTrials.gov Identifier: | NCT01449565 History of Changes |
Other Study ID Numbers: |
R01DA031678 ( U.S. NIH Grant/Contract ) |
First Posted: | October 10, 2011 Key Record Dates |
Last Update Posted: | April 13, 2016 |
Last Verified: | April 2016 |
Keywords provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:
methamphetamine high-risk sexual behavior HIV prevention |
Additional relevant MeSH terms:
Amphetamine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone Methamphetamine Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Central Nervous System Stimulants |
Sympathomimetics Autonomic Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors |