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

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
Methamphetamine
Drug: mirtazapine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up

Resource links provided by NLM:


Further study details as provided by San Francisco Department of Public Health:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mirtazapine
mirtazapine 30 mg orally per day
Drug: mirtazapine
Other Name: Remeron
Placebo Comparator: Placebo
placebo (30 mg) orally per day
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888835

Contacts
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

Locations
United States, California
San Francisco Department of Public Health Recruiting
San Francisco, California, United States, 94102
Contact: Phillip O Coffin, M.D.    415-437-6282    phillip.coffin@sfdph.org   
Contact: Deirdre M Santos, N.P.    (415) 437-6227    deirdre.santos@sfdph.org   
Principal Investigator: Phillip O Coffin, M.D.         
Principal Investigator: Steven L Batki, M.D.         
Sub-Investigator: Eric Vittinghoff, PhD, MPH         
Sub-Investigator: Glenn-Milo Santos, MPH, PhDc         
Sponsors and Collaborators
Phillip Coffin, MD, MIA
Investigators
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
  More Information

No publications provided

Responsible Party: Phillip Coffin, MD, MIA, Director, Substance Use Research Unit, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT01888835     History of Changes
Other Study ID Numbers: 1R01DA034527
Study First Received: June 25, 2013
Last Updated: February 4, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by San Francisco Department of Public Health:
HIV
sexual behavior

Additional relevant MeSH terms:
Methamphetamine
Mirtazapine
Mianserin
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on April 22, 2014