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Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)

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ClinicalTrials.gov Identifier: NCT01888835
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date March 13, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Number of methamphetamine-positive urine tests [ Time Frame: weekly for 9 months ]
To determine the efficacy of mirtazapine vs placebo at 12 weeks and 24 weeks of treatment plus counseling, and to determine whether efficacy is sustained for an additional 12 weeks after discontinuation of treatment and counseling (weeks 24 to 36).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01888835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Sexual risk (see description) [ Time Frame: 9 months ]
To assess if the intervention reduces HIV risk behaviors, including number of male sex partners, number of male anal sex partners with whom meth is used and episodes of unprotected anal sex with serodiscordant partners.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 27, 2013)
  • Adherence to study drug [ Time Frame: 6 months ]
    To measure the acceptability of mirtazapine and placebo by determining (via electronic pill boxes and self-report) medication adherence including percent of doses taken, taking less than 80% of medication, patterns of non-adherence (e.g. use every other day, during the weekend, longer alternating periods on and off medication), and time to stopping medication.
  • Number of adverse events [ Time Frame: 6 months ]
    To measure the tolerability of mirtazapine and placebo, as determined by the number of adverse clinical events in the mirtazapine and placebo arms.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
Official Title  ICMJE Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up
Brief Summary The investigators recently conducted a double-blind, randomized controlled trial (n=60) of limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine, as determined by reduction in meth-positive urines. Sexual risk behaviors also declined significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily doses were taken. All participants received weekly substance use counseling and monthly, brief clinician-delivered adherence counseling. The investigators propose expanding upon these results by lengthening the treatment period to 24 weeks, with adherence reminders added to the counseling, and determining if efficacy is sustained up to 12 weeks after drug discontinuation. The sample size for this 9-month study is 120.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amphetamine-Related Disorders
Intervention  ICMJE
  • Drug: Mirtazapine
    Other Name: Remeron
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Mirtazapine
    mirtazapine 30 mg orally per day
    Intervention: Drug: Mirtazapine
  • Placebo Comparator: Placebo
    placebo (30 mg) orally per day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. born male, or born female and does not identify as female;
  2. reports anal sex with men in the prior three months while under the influence of meth;
  3. diagnosed with meth dependence by SCID;
  4. interested in stopping or reducing meth use;
  5. at least one meth-positive urine during screening and run-in period;
  6. no current acute illness requiring prolonged medical care;
  7. no serious chronic illnesses that are likely to progress clinically during trial participation;
  8. able and willing to provide informed consent and adhere to visit schedule;
  9. age 18-69 years;
  10. baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by clinician in conjunction with symptoms, physical exam, and medical history
  11. current CD4 count ≥ 200 cells/mm3; or CD4 count of 100 - 199 cells/mm3 and HIV viral load < 200 copies/mL
  12. text-capable cell phone or access to email

Exclusion Criteria:

  1. Evidence of current major depression by SCID;
  2. history of bipolar disorder or psychotic disorder, as determined by SCID;
  3. known allergy or previous adverse reaction to mirtazapine;
  4. taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamineoxidase inhibitor;
  5. moderate or severe liver disease (AST, ALT, and total bilirubin >= 5 times upper limit of normal);
  6. impaired renal function (estimated GFR <40 ml/min);
  7. currently participating in another research study;
  8. pending legal proceedings with high risk for incarceration during the time of planned study participation;
  9. any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888835
Other Study ID Numbers  ICMJE 1R01DA034527( U.S. NIH Grant/Contract )
R01DA034527 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phillip Coffin, MD, MIA, San Francisco Department of Public Health
Study Sponsor  ICMJE Phillip Coffin, MD, MIA
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Phillip O Coffin, M.D. San Francisco Department of Public Health
Principal Investigator: Steven L Batki, M.D. University of California, San Francisco
Study Director: Emily Behar San Francisco Department of Public Health
PRS Account San Francisco Department of Public Health
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP