Trial Outcomes & Findings for Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM (NCT NCT00318409)
NCT ID: NCT00318409
Last Updated: 2014-10-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
At Enrollment
Results posted on
2014-10-17
Participant Flow
Participants were actively recruited at the municipal STD and HIV clinics, and by street outreach. Recruitment flyers were posted at locations of active recruitment, in local newspapers and in print media and on social networking websites.
After informed consent, participants were screened in two screening visits, with lab and HIV testing, medical history and physical exam, and urine meth testing.
Participant milestones
| Measure |
Bupropion
Bupropion XL 300mg daily
|
Placebo
Placebo 300mg daily
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
Baseline characteristics by cohort
| Measure |
Bupropion
n=20 Participants
Bupropion XL 300mg daily
|
Placebo
n=10 Participants
Placebo 300mg daily
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
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
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At EnrollmentOutcome measures
| Measure |
Persons Screened
n=54 Participants
|
Placebo
|
|---|---|---|
|
Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled
|
30 Eligible persons screened who enrolled
|
—
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Persons Screened
n=240 Study visits after enrollment
|
Placebo
n=120 Study visits after enrollment
|
|---|---|---|
|
Feasibility: Proportion of Scheduled Study Visits Completed
|
185 Scheduled study visits completed
|
96 Scheduled study visits completed
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Persons Screened
n=240 Study visits post enrollment
|
Placebo
n=120 Study visits post enrollment
|
|---|---|---|
|
Feasibility: Proportion of Urine Samples Collected
|
193 Urine samples collected
|
97 Urine samples collected
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Persons Screened
n=20 Participants
|
Placebo
n=10 Participants
|
|---|---|---|
|
Feasibility: Participants Who Completed the Trial
|
18 participants who completed the trial
|
9 participants who completed the trial
|
PRIMARY outcome
Timeframe: throughout studyOutcome measures
| Measure |
Persons Screened
n=20 Participants
|
Placebo
n=10 Participants
|
|---|---|---|
|
Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.
|
40 number of adverse events
|
11 number of adverse events
|
PRIMARY outcome
Timeframe: 12 weeksProportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.
Outcome measures
| Measure |
Persons Screened
n=20 Participants
|
Placebo
n=10 Participants
|
|---|---|---|
|
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings
|
59 percentage adherence by MEMS
|
62 percentage adherence by MEMS
|
PRIMARY outcome
Timeframe: 12 weeksProportional of reported days taking study drug during the 12 weeks of study.
Outcome measures
| Measure |
Persons Screened
n=20 Participants
|
Placebo
n=10 Participants
|
|---|---|---|
|
Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report
|
85 percentage of self-reported adherence
|
75 percentage of self-reported adherence
|
PRIMARY outcome
Timeframe: 12 weeksProportion of participants who discontinued study medication for at least one week prior to study completion.
Outcome measures
| Measure |
Persons Screened
n=20 Participants
|
Placebo
n=10 Participants
|
|---|---|---|
|
Acceptability: Proportion of Participants Discontinuing Medication in Both Arms
|
15 percentage of discontinuations
|
30 percentage of discontinuations
|
Adverse Events
Bupropion
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupropion
n=20 participants at risk
|
Placebo
n=10 participants at risk
|
|---|---|---|
|
Infections and infestations
Soft tissue infection
|
20.0%
4/20 • Number of events 5 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Injury, poisoning and procedural complications
Stimulant toxicity
|
0.00%
0/20 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Immune system disorders
Allergic reaction to antibiotics
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Investigations
Decreased CD4
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Reproductive system and breast disorders
Decreased libido
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
Epididymitis
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
General disorders
Flu-like symptoms
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
15.0%
3/20 • Number of events 3 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Infections and infestations
Sexually transmitted infection
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Immune system disorders
HIV Seroconversion
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
10.0%
2/20 • Number of events 3 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Number of events 2 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Hepatobiliary disorders
Increased ALT
|
20.0%
4/20 • Number of events 5 • 12 weeks
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
|
Hepatobiliary disorders
Increased AST
|
15.0%
3/20 • Number of events 3 • 12 weeks
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
Increased creatinine
|
15.0%
3/20 • Number of events 3 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
General disorders
Sleep Disturbances
|
10.0%
2/20 • Number of events 2 • 12 weeks
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.0%
1/20 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 2 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
10.0%
2/20 • Number of events 2 • 12 weeks
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
Additional Information
Moupali Das, MD, MPH
San Francisco Department of Public Health
Phone: 415-437-6204
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place