Trial Outcomes & Findings for Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors (NCT NCT00497081)
NCT ID: NCT00497081
Last Updated: 2015-01-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline (week 0) and Final Visit (week 12)
Results posted on
2015-01-05
Participant Flow
Participant milestones
| Measure |
Active Comparator:
mirtazapine 30 mg daily for 3 months
|
Placebo Comparator:
placebo 30 mg daily for 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors
Baseline characteristics by cohort
| Measure |
Active Comparator:
n=30 Participants
mirtazapine 30 mg daily for 3 months
|
Placebo Comparator:
n=30 Participants
placebo 30 mg daily for 3 months
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
60 • n=5 Participants
|
19 participants
63 • n=7 Participants
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 participants
20 • n=5 Participants
|
5 participants
17 • n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
3 participants
10 • n=5 Participants
|
4 participants
13 • n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
10 • n=5 Participants
|
2 participants
7 • n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) and Final Visit (week 12)Outcome measures
| Measure |
Active Comparator:
n=30 Participants
mirtazapine 30 mg daily for 3 months
|
Placebo Comparator:
n=30 Participants
placebo 30 mg daily for 3 months
|
|---|---|---|
|
Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).
|
40 Percentage reduction
|
6 Percentage reduction
|
PRIMARY outcome
Timeframe: Daily, from Baseline (week 0) through Final Visit (week 12)Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).
Outcome measures
| Measure |
Active Comparator:
n=30 Participants
mirtazapine 30 mg daily for 3 months
|
Placebo Comparator:
n=30 Participants
placebo 30 mg daily for 3 months
|
|---|---|---|
|
Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.
|
48.3 Percentage of recorded openings
Standard Deviation 26.9
|
48.7 Percentage of recorded openings
Standard Deviation 26.9
|
PRIMARY outcome
Timeframe: From Baseline (week 0) through Final Visit (week 12)Outcome measures
| Measure |
Active Comparator:
n=30 Participants
mirtazapine 30 mg daily for 3 months
|
Placebo Comparator:
n=30 Participants
placebo 30 mg daily for 3 months
|
|---|---|---|
|
Frequency of Adverse Events Reported
|
109 Adverse Events Reported
|
107 Adverse Events Reported
|
Adverse Events
Active Comparator:
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo Comparator:
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Comparator:
n=30 participants at risk
mirtazapine 30 mg daily for 3 months
|
Placebo Comparator:
n=30 participants at risk
placebo 30 mg daily for 3 months
|
|---|---|---|
|
Injury, poisoning and procedural complications
Compression (spine)
|
0.00%
0/30 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Meth-induced Psychosis
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
Other adverse events
| Measure |
Active Comparator:
n=30 participants at risk
mirtazapine 30 mg daily for 3 months
|
Placebo Comparator:
n=30 participants at risk
placebo 30 mg daily for 3 months
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
43.3%
13/30 • Number of events 19 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Hepatobiliary disorders
Increased ALT
|
23.3%
7/30 • Number of events 10 • 12 weeks
|
30.0%
9/30 • Number of events 12 • 12 weeks
|
|
Hepatobiliary disorders
Increased AST
|
16.7%
5/30 • Number of events 7 • 12 weeks
|
26.7%
8/30 • Number of events 11 • 12 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
13.3%
4/30 • Number of events 4 • 12 weeks
|
13.3%
4/30 • Number of events 4 • 12 weeks
|
|
Infections and infestations
Gonorrhea
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
Increased Creatinine
|
6.7%
2/30 • Number of events 2 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
2/30 • Number of events 3 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
4/30 • Number of events 5 • 12 weeks
|
10.0%
3/30 • Number of events 4 • 12 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
6.7%
2/30 • Number of events 2 • 12 weeks
|
13.3%
4/30 • Number of events 5 • 12 weeks
|
|
Metabolism and nutrition disorders
Increased Appetite
|
13.3%
4/30 • Number of events 4 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • Number of events 4 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Metabolism and nutrition disorders
Weight Gain
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
13.3%
4/30 • Number of events 5 • 12 weeks
|
|
Infections and infestations
Skin and Soft Tissue Infection
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
23.3%
7/30 • Number of events 10 • 12 weeks
|
|
Hepatobiliary disorders
Increased Alkaline Phosphatase
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
13.3%
4/30 • Number of events 4 • 12 weeks
|
|
Nervous system disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
10.0%
3/30 • Number of events 3 • 12 weeks
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
6.7%
2/30 • Number of events 2 • 12 weeks
|
Additional Information
Glenn-Milo Santos, MPH
San Francisco Department of Public Health
Phone: 415.437.6231
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place