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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00497081
Recruitment Status : Completed
First Posted : July 6, 2007
Results First Posted : October 20, 2014
Last Update Posted : January 5, 2015
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Substance Abuse
HIV Infections
Interventions: Drug: mirtazapine
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Active Comparator: mirtazapine 30 mg daily for 3 months
Placebo Comparator: placebo 30 mg daily for 3 months

Participant Flow:   Overall Study
    Active Comparator:   Placebo Comparator:
STARTED   30   30 
COMPLETED   28   28 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Active Comparator: mirtazapine 30 mg daily for 3 months
Placebo Comparator: placebo 30 mg daily for 3 months
Total Total of all reporting groups

Baseline Measures
   Active Comparator:   Placebo Comparator:   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
[Units: Years]
Mean (Standard Deviation)
 40.9  (8.0)   40.1  (10.1)   40.5  (9.0) 
[Units: Participants]
Female   0   0   0 
Male   30   30   60 
Race/Ethnicity, Customized 
[Units: Participants]
White   18   19   37 
African American   6   5   11 
Latino   3   4   7 
Other   3   2   5 

  Outcome Measures

1.  Primary:   Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).   [ Time Frame: Baseline (week 0) and Final Visit (week 12) ]

2.  Primary:   Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.   [ Time Frame: Daily, from Baseline (week 0) through Final Visit (week 12) ]

3.  Primary:   Frequency of Adverse Events Reported   [ Time Frame: From Baseline (week 0) through Final Visit (week 12) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Glenn-Milo Santos, MPH
Organization: San Francisco Department of Public Health
phone: 415.437.6231
e-mail: glenn-milo.santos@sfdph.org

Publications of Results:

Responsible Party: Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT00497081     History of Changes
Other Study ID Numbers: 1R01DA022155-01 ( U.S. NIH Grant/Contract )
R01DA022155 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: July 5, 2007
First Posted: July 6, 2007
Results First Submitted: October 7, 2014
Results First Posted: October 20, 2014
Last Update Posted: January 5, 2015