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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by San Francisco Department of Public Health
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:
NCT01888835
First received: June 25, 2013
Last updated: February 4, 2014
Last verified: February 2014

June 25, 2013
February 4, 2014
August 2013
December 2017   (final data collection date for primary outcome measure)
Number of methamphetamine-positive urine tests [ Time Frame: weekly for 9 months ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01888835 on ClinicalTrials.gov Archive Site
Sexual risk (see description) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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.
Same as current
  • Adherence to study drug [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To measure the tolerability of mirtazapine and placebo, as determined by the number of adverse clinical events in the mirtazapine and placebo arms.
Same as current
 
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Methamphetamine
  • Drug: mirtazapine
    Other Name: Remeron
  • Drug: Placebo
  • Active Comparator: Mirtazapine
    mirtazapine 30 mg orally per day
    Intervention: Drug: mirtazapine
  • Placebo Comparator: Placebo
    placebo (30 mg) orally per day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2017
December 2017   (final data collection date for primary outcome measure)

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.
Male
18 Years to 69 Years
No
Contact: Phillip O Coffin, M.D. (415) 437-6282 phillip.coffin@sfdph.org
Contact: Jason D Euren, M.A. (415) 437-6276 jason.euren@sfdph.org
United States
 
NCT01888835
1R01DA034527
Yes
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
Phillip Coffin, MD, MIA
National Institute on Drug Abuse (NIDA)
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: Deirdre M Santos, N.P. San Francisco Department of Public Health
Study Director: Jason D Euren, MA San Francisco Department of Public Health
San Francisco Department of Public Health
February 2014

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