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

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ClinicalTrials.gov Identifier: NCT01888835
Recruitment Status : Active, not recruiting
First Posted : June 28, 2013
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Amphetamine-Related Disorders Drug: Mirtazapine Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : August 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
Drug Information available for: Mirtazapine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of methamphetamine-positive urine tests [ Time Frame: weekly for 9 months ]
    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 :
  1. Sexual risk (see description) [ Time Frame: 9 months ]
    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:
  1. Adherence to study drug [ Time Frame: 6 months ]
    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.

  2. Number of adverse events [ Time Frame: 6 months ]
    To measure the tolerability of mirtazapine and placebo, as determined by the number of adverse clinical events in the mirtazapine and placebo arms.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888835


Locations
United States, California
Substance Use Research Unit
San Francisco, California, United States, 94102
Sponsors and Collaborators
Phillip Coffin, MD, MIA
National Institute on Drug Abuse (NIDA)
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: Jaclyn Hern, MPH San Francisco Department of Public Health
More Information

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 ( U.S. NIH Grant/Contract )
R01DA034527 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Phillip Coffin, MD, MIA, San Francisco Department of Public Health:
HIV
sexual behavior

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Mirtazapine
Mianserin
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents