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

NCT01888835 | Completed Phase 2 DMC

• 2 other identifiers: 1R01DA034527R01DA034527
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Amphetamine-Related Disorders

Keywords

HIV; sexual behavior

Outcome Measures

Primary Outcomes (1)

• Number of methamphetamine-positive urine tests

  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).

  weekly for 9 months

Secondary Outcomes (1)

• Sexual risk (see description)

  9 months

Other Outcomes (2)

• Adherence to study drug

  6 months

• Number of adverse events

  6 months

Study Arms (2)

Mirtazapine

ACTIVE COMPARATOR

mirtazapine 30 mg orally per day

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

placebo (30 mg) orally per day

Drug: Placebo

Interventions

Mirtazapine DRUG

Also known as: Remeron

Mirtazapine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• born male, or born female and does not identify as female;
• reports anal sex with men in the prior three months while under the influence of meth;
• diagnosed with meth dependence by SCID;
• interested in stopping or reducing meth use;
• at least one meth-positive urine during screening and run-in period;
• no current acute illness requiring prolonged medical care;
• no serious chronic illnesses that are likely to progress clinically during trial participation;
• able and willing to provide informed consent and adhere to visit schedule;
• age 18-69 years;
• 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
• current CD4 count ≥ 200 cells/mm3; or CD4 count of 100 - 199 cells/mm3 and HIV viral load \< 200 copies/mL
• text-capable cell phone or access to email

You may not qualify if:

• Evidence of current major depression by SCID;
• history of bipolar disorder or psychotic disorder, as determined by SCID;
• known allergy or previous adverse reaction to mirtazapine;
• taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamineoxidase inhibitor;
• moderate or severe liver disease (AST, ALT, and total bilirubin \>= 5 times upper limit of normal);
• impaired renal function (estimated GFR \<40 ml/min);
• 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.

Sponsors & Collaborators

• Phillip Coffin, MD, MIA: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Substance Use Research Unit

San Francisco, California, 94102, United States

Location

Related Publications (1)

• Coffin PO, Santos GM, Hern J, Vittinghoff E, Walker JE, Matheson T, Santos D, Colfax G, Batki SL. Effects of Mirtazapine for Methamphetamine Use Disorder Among Cisgender Men and Transgender Women Who Have Sex With Men: A Placebo-Controlled Randomized Clinical Trial. JAMA Psychiatry. 2020 Mar 1;77(3):246-255. doi: 10.1001/jamapsychiatry.2019.3655.

  PMID: 31825466 DERIVED

MeSH Terms

Conditions

Amphetamine-Related Disorders; Sexual Behavior

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Phillip O Coffin, M.D.

  San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

• Steven L Batki, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Emily Behar

  San Francisco Department of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Substance Use Research Unit

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 28, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

US (1)