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

This study has been completed.
Sponsor:
Collaborators:
Public Health Foundation Enterprises, Inc.
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:
NCT00497081
First received: July 5, 2007
Last updated: October 15, 2014
Last verified: October 2014
Results First Received: October 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Substance Abuse
HIV Infections
Interventions: Drug: mirtazapine
Drug: placebo

  Participant Flow
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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
  Description
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  
NOT COMPLETED     2     2  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: years]
Mean ± Standard Deviation
  40.9  ± 8.0     40.1  ± 10.1     40.5  ± 9.0  
Gender  
[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
  Show All 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
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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
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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: 1 R01 DA022155-01, R01DA022155, 1R01DA022155-01, DPMC
Study First Received: July 5, 2007
Results First Received: October 7, 2014
Last Updated: October 15, 2014
Health Authority: United States: Federal Government