Status:
COMPLETED
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
Lead Sponsor:
Phillip Coffin, MD, MIA
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Amphetamine-Related Disorders
Eligibility:
MALE
18-69 years
Phase:
PHASE2
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 antidepr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01888835
Start Date
August 1 2013
End Date
October 1 2017
Last Update
March 13 2018
Active Locations (1)
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1
Substance Use Research Unit
San Francisco, California, United States, 94102