Trial Outcomes & Findings for Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents (NCT NCT00994448)
NCT ID: NCT00994448
Last Updated: 2013-04-04
Results Overview
the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
8 weeks
Results posted on
2013-04-04
Participant Flow
substance abuse clinic, community outreach
Reasons for not being randomized were: withdrew voluntarily (4), failed to complete assessments (2), psychiatric disorder (2), weight \< 50 kg (2), alcohol dependent (1), and incarcerated (1).
Participant milestones
| Measure |
Bupropion
Bupropion SR 150 mg twice a day
|
Placebo (Sugar Pill)
Matching placebo tablets twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Bupropion
Bupropion SR 150 mg twice a day
|
Placebo (Sugar Pill)
Matching placebo tablets twice a day
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Pilot Trial of Bupropion Versus Placebo for Methamphetamine Abuse in Adolescents
Baseline characteristics by cohort
| Measure |
Bupropion
n=12 Participants
Bupropion SR 150 mg twice a day
|
Placebo (Sugar Pill)
n=7 Participants
Matching placebo tablets twice a day
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
17.5 years
STANDARD_DEVIATION 1.6 • n=99 Participants
|
17.7 years
STANDARD_DEVIATION 1.1 • n=107 Participants
|
17.5 years
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
7 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: mean days retained in treatment for each grou\[p
the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)
Outcome measures
| Measure |
Bupropion
n=12 Participants
Bupropion SR 150 mg twice a day
|
Placebo (Sugar Pill)
n=7 Participants
Matching placebo tablets twice a day
|
|---|---|---|
|
Feasibility of Retaining Adolescents in Trial
|
33.3 days
Standard Deviation 21.2
|
49.3 days
Standard Deviation 9.8
|
Adverse Events
Bupropion
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo (Sugar Pill)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupropion
n=12 participants at risk
Bupropion SR 150 mg twice a day
|
Placebo (Sugar Pill)
n=7 participants at risk
Matching placebo tablets twice a day
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
Other adverse events
| Measure |
Bupropion
n=12 participants at risk
Bupropion SR 150 mg twice a day
|
Placebo (Sugar Pill)
n=7 participants at risk
Matching placebo tablets twice a day
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Flu symptoms
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Upper Respiratory Infection
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Blurry Vision
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Cold Sore
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Meth cravings
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Upset Stomach
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place