Back to resultsExtended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM) (TREX)
Primary Purpose
Amphetamine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring methamphetamine, high-risk sexual behavior, HIV prevention
Eligibility Criteria
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.
Sites / Locations
- Substance Use Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Naltrexone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
urine meth positivity
proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12
Secondary Outcome Measures
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
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
rates of adverse events
rates of adverse events will be compared by study arm
Full Information
NCT ID
NCT01449565
First Posted
October 4, 2011
Last Updated
April 11, 2016
Sponsor
San Francisco Department of Public Health
Collaborators
Alkermes, Inc., National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01449565
Brief Title
Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)
Acronym
TREX
Official Title
Extended-Release Naltrexone (XR-NTX, VIVITROL) for the Treatment of Actively-Using Methamphetamine-Dependent Men Who Have Sex With Men
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Department of Public Health
Collaborators
Alkermes, Inc., National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
Keywords
methamphetamine, high-risk sexual behavior, HIV prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naltrexone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
XR-NTX, VIVITROL
Intervention Description
3 monthly intramuscular injections of naltrexone 380 mg (extended release)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)
Primary Outcome Measure Information:
Title
urine meth positivity
Description
proportion of meth-metabolite positive urines by study arm, measured weekly from week 0 through week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
reduction in sexual risk behavior
Description
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
Time Frame
12 weeks
Title
percentage of total expected injections administered
Description
acceptability of extended-release naltrexone vs placebo, as measured by the percentage of total expected injections administered, by study arm
Time Frame
12 weeks
Title
rates of adverse events
Description
rates of adverse events will be compared by study arm
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L. Batki, MD
Organizational Affiliation
Substance Abuse Programs, San Francisco VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phillip Coffin, MD, MIA
Organizational Affiliation
Substance Use Research Unit, San Francisco Department of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily Behar, MS
Organizational Affiliation
San Francisco Department of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Substance Use Research Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)
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