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

Amphetamine-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888835
• Other study ID #: 1R01DA034527
• Secondary ID: R01DA034527
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2013
• Last updated: March 9, 2018
• Start date: August 2013
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: San Francisco Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amphetamine-Related Disorders

Intervention

Drug:
• Mirtazapine

• Placebo

Locations

Country	Name	City	State
United States	Substance Use Research Unit	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Phillip Coffin, MD, MIA	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to study drug	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.	6 months
Other	Number of adverse events	To measure the tolerability of mirtazapine and placebo, as determined by the number of adverse clinical events in the mirtazapine and placebo arms.	6 months
Primary	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	Sexual risk (see description)	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.	9 months