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

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ClinicalTrials.gov Identifier: NCT00497081
Recruitment Status : Completed
First Posted : July 6, 2007
Results First Posted : October 20, 2014
Last Update Posted : January 5, 2015
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Public Health Foundation Enterprises, Inc.
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health

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
Enrollment 60

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Comparator: Placebo Comparator:
Hide Arm/Group Description mirtazapine 30 mg daily for 3 months placebo 30 mg daily for 3 months
Period Title: Overall Study
Started 30 30
Completed 28 28
Not Completed 2 2
Arm/Group Title Active Comparator: Placebo Comparator: Total
Hide Arm/Group Description mirtazapine 30 mg daily for 3 months placebo 30 mg daily for 3 months Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
40.9  (8.0) 40.1  (10.1) 40.5  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
30
 100.0%
30
 100.0%
60
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
White 18 19 37
African American 6 5 11
Latino 3 4 7
Other 3 2 5
1.Primary Outcome
Title Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).
Hide Description [Not Specified]
Time Frame Baseline (week 0) and Final Visit (week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator: Placebo Comparator:
Hide Arm/Group Description:
mirtazapine 30 mg daily for 3 months
placebo 30 mg daily for 3 months
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Percentage reduction
40 6
2.Primary Outcome
Title Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.
Hide Description Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).
Time Frame Daily, from Baseline (week 0) through Final Visit (week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator: Placebo Comparator:
Hide Arm/Group Description:
mirtazapine 30 mg daily for 3 months
placebo 30 mg daily for 3 months
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Percentage of recorded openings
48.3  (26.9) 48.7  (26.9)
3.Primary Outcome
Title Frequency of Adverse Events Reported
Hide Description [Not Specified]
Time Frame From Baseline (week 0) through Final Visit (week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator: Placebo Comparator:
Hide Arm/Group Description:
mirtazapine 30 mg daily for 3 months
placebo 30 mg daily for 3 months
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Adverse Events Reported
109 107
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator: Placebo Comparator:
Hide Arm/Group Description mirtazapine 30 mg daily for 3 months placebo 30 mg daily for 3 months
All-Cause Mortality
Active Comparator: Placebo Comparator:
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Comparator: Placebo Comparator:
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      1/30 (3.33%)    
Injury, poisoning and procedural complications     
Compression (spine)  0/30 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders     
Meth-induced Psychosis  1/30 (3.33%)  1 0/30 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Comparator: Placebo Comparator:
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/30 (90.00%)      24/30 (80.00%)    
Gastrointestinal disorders     
Gastroenteritis  4/30 (13.33%)  4 4/30 (13.33%)  4
Diarrhea  2/30 (6.67%)  4 1/30 (3.33%)  1
Constipation  1/30 (3.33%)  1 3/30 (10.00%)  3
Hepatobiliary disorders     
Increased ALT  7/30 (23.33%)  10 9/30 (30.00%)  12
Increased AST  5/30 (16.67%)  7 8/30 (26.67%)  11
Hyperbilirubinemia  2/30 (6.67%)  2 4/30 (13.33%)  5
Increased Alkaline Phosphatase  1/30 (3.33%)  1 4/30 (13.33%)  4
Infections and infestations     
Gonorrhea  3/30 (10.00%)  3 1/30 (3.33%)  1
Skin and Soft Tissue Infection  3/30 (10.00%)  3 7/30 (23.33%)  10
Metabolism and nutrition disorders     
Hypoglycemia  2/30 (6.67%)  3 0/30 (0.00%)  0
Hyperglycemia  4/30 (13.33%)  5 3/30 (10.00%)  4
Increased Appetite  4/30 (13.33%)  4 0/30 (0.00%)  0
Hypocalcemia  3/30 (10.00%)  3 0/30 (0.00%)  0
Weight Gain  3/30 (10.00%)  3 0/30 (0.00%)  0
Nervous system disorders     
Drowsiness  13/30 (43.33%)  19 0/30 (0.00%)  0
Insomnia  1/30 (3.33%)  1 3/30 (10.00%)  3
Psychiatric disorders     
Depression  1/30 (3.33%)  1 2/30 (6.67%)  2
Renal and urinary disorders     
Increased Creatinine  2/30 (6.67%)  2 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection  3/30 (10.00%)  3 4/30 (13.33%)  5
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
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 )
1R01DA022155-01 ( 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