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

Information source: San Francisco Department of Public Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amphetamine-Related Disorders

Intervention: Mirtazapine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Phillip Coffin, MD, MIA

Official(s) and/or principal investigator(s):
Phillip O Coffin, M.D., Principal Investigator, Affiliation: San Francisco Department of Public Health
Steven L Batki, M.D., Principal Investigator, Affiliation: University of California, San Francisco
Jaclyn Hern, MPH, Study Director, Affiliation: San Francisco Department of Public Health

Overall contact:
Phillip O Coffin, M.D., Phone: (415) 437-6282, Email: phillip.coffin@sfdph.org

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.

Clinical Details

Official title: Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of methamphetamine-positive urine tests

Secondary outcome: Sexual risk (see description)

Eligibility

Minimum age: 18 Years. Maximum age: 69 Years. Gender(s): Male.

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.

Locations and Contacts

Phillip O Coffin, M.D., Phone: (415) 437-6282, Email: phillip.coffin@sfdph.org

Substance Use Research Unit, San Francisco, California 94102, United States; Recruiting
Phillip O Coffin, M.D., Phone: 415-437-6282, Email: phillip.coffin@sfdph.org
Deirdre M Santos, N.P., Phone: (415) 437-6227, Email: deirdre.santos@sfdph.org
Phillip O Coffin, M.D., Principal Investigator
Steven L Batki, M.D., Principal Investigator
Eric Vittinghoff, PhD, MPH, Sub-Investigator
Glenn-Milo Santos, MPH, PhDc, Sub-Investigator
Additional Information

Starting date: August 2013
Last updated: August 18, 2015

Page last updated: August 23, 2015

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