Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors

NCT00497081 | Completed Phase 2 Results DMC

• 3 other identifiers: 1R01DA022155-01R01DA022155DPMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or acquiring HIV. This study of intermediate size (60 participants) and length (3 months of follow-up) will assess the efficacy of mirtazapine in reducing methamphetamine use among high-risk MSM.

Conditions

Substance Abuse; HIV Infections

Keywords

Methamphetamine; HIV; MSM; HIV Seronegativity

Outcome Measures

Primary Outcomes (3)

• Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).

  Baseline (week 0) and Final Visit (week 12)

• Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.

  Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).

  Daily, from Baseline (week 0) through Final Visit (week 12)

• Frequency of Adverse Events Reported

  From Baseline (week 0) through Final Visit (week 12)

Study Arms (2)

Mirtazapine

ACTIVE COMPARATOR

mirtazapine 30 mg daily

Drug: mirtazapine

Placebo

PLACEBO COMPARATOR

placebo 30 mg daily

Drug: placebo

Interventions

mirtazapine DRUG

mirtazapine 30 mg daily for 3 months

Also known as: Remeron

Mirtazapine

placebo DRUG

placebo 30 mg daily for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV-negative by rapid test, or documentation of HIV infection with a laboratory result of a positive HIV test;
• male gender;
• reports having anal sex with men in the prior 3 months while using methamphetamine;
• diagnosed with methamphetamine dependence as determined by SCID;
• interested in stopping or reducing methamphetamine use;
• at least one methamphetamine-positive urine at screening and run-in period;
• no known allergies to mirtazapine;
• no current acute illnesses requiring prolonged medical care;
• no chronic illnesses that are likely to progress clinically during trial participation;
• able and willing to provide informed consent and to be followed over a 3-month period;
• age 18-60 years;
• baseline CBC, total protein, albumin, glucose, alk phos, creatinine, BUN and electrolytes without clinically significant abnormalities as determined by investigator in conjunction with symptoms, physical exam, and medical history.

You may not qualify if:

• evidence of current major depression, as determined by SCID;70
• history of bipolar disorder or psychosis, as determined by SCID;
• taking anti-depressant or other psychotropic medication within the last 30 days, including mirtazapine or a monoamine oxidase (MAO) inhibitor;
• currently using or unwilling not to use pseudoephedrine-containing products for trial duration (causes false positive urines for methamphetamine use);
• current CD4 count \< 200 cells/mm3;
• measured moderate or severe liver disease (AST, ALT, and total bilirubin \> 3 times upper limit of normal) and/or any symptoms of current liver disease;
• impaired renal function (creatinine clearance \< 60 ml/min);
• currently participating in another research study;
• any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.

Sponsors & Collaborators

• San Francisco Department of Public Health: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Public Health Foundation Enterprises, Inc.: collaborator

Study Sites (1)

San Francisco Department of Public Health, Substance Use Research Unit

San Francisco, California, 94102, United States

Location

Related Publications (1)

• Colfax GN, Santos GM, Das M, Santos DM, Matheson T, Gasper J, Shoptaw S, Vittinghoff E. Mirtazapine to reduce methamphetamine use: a randomized controlled trial. Arch Gen Psychiatry. 2011 Nov;68(11):1168-75. doi: 10.1001/archgenpsychiatry.2011.124.

  PMID: 22065532 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; HIV Infections

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Glenn-Milo Santos, MPH
• Organization: San Francisco Department of Public Health

glenn-milo.santos@sfdph.org

415.437.6231

Study Officials

• Grant N Colfax, MD

  Co-Directior, HIV Epidemiology Section, San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 5, 2015
• Results First Posted: October 20, 2014

Record last verified: 2014-12

Locations

US (1)