Trial Outcomes & Findings for Bupropion for ADHD in Adolescents With Substance Use Disorder (NCT NCT00936299)
NCT ID: NCT00936299
Last Updated: 2019-12-23
Results Overview
DSM-IV ADHD Rating Scale (ADHD-RS) Total Score (clinician administered/adolescent informant). Total scale range 0-54, higher is greater severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
Baseline, 16 Weeks
Results posted on
2019-12-23
Participant Flow
Participant milestones
| Measure |
Bupropion + Cognitive Behavioral Therapy
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
|
Placebo + Cognitive Behavioral Therapy
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bupropion for ADHD in Adolescents With Substance Use Disorder
Baseline characteristics by cohort
| Measure |
Bupropion + Cognitive Behavioral Therapy
n=53 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
|
Placebo + Cognitive Behavioral Therapy
n=52 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.8 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
17.8 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
17.8 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
52 participants
n=7 Participants
|
105 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksDSM-IV ADHD Rating Scale (ADHD-RS) Total Score (clinician administered/adolescent informant). Total scale range 0-54, higher is greater severity.
Outcome measures
| Measure |
Bupropion + Cognitive Behavioral Therapy
n=53 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
|
Placebo + Cognitive Behavioral Therapy
n=52 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
|---|---|---|
|
Change in ADHD Rating Scale (ADHD-RS) Total Score
|
-14.2 units on a scale
Interval -17.1 to -11.4
|
-13.8 units on a scale
Interval -16.6 to -11.1
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksThe number of days of cigarette smoking in the past 28 days was ascertained based on adolescent self-report using calendar-based timeline follow back procedures. Mean number of days of past 28-day cigarette smoking at baseline was compared to mean number of days of past 28-day cigarette smoking at end of 16-week trial.
Outcome measures
| Measure |
Bupropion + Cognitive Behavioral Therapy
n=53 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
|
Placebo + Cognitive Behavioral Therapy
n=52 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
|---|---|---|
|
Change in Number of Days of Cigarette Smoking in Past 28 Days
|
-4.1 days of use
Interval -6.7 to -1.5
|
-2.7 days of use
Interval -5.3 to -0.1
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksThe number of days of cannabis use in the past 28 days was ascertained based on adolescent self-report using calendar-based timeline follow back procedures. Mean number of days of past 28-day cannabis use at baseline was compared to mean number of days of past 28-day cannabis use at end of 16-week trial.
Outcome measures
| Measure |
Bupropion + Cognitive Behavioral Therapy
n=53 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
|
Placebo + Cognitive Behavioral Therapy
n=52 Participants
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
|---|---|---|
|
Change in Number of Days of Cannabis Use in Past 28 Days
|
-4.7 days of use
Interval -7.6 to -1.8
|
-6.5 days of use
Interval -9.4 to -3.6
|
Adverse Events
Bupropion + Cognitive Behavioral Therapy
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo + Cognitive Behavioral Therapy
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupropion + Cognitive Behavioral Therapy
n=53 participants at risk
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
|
Placebo + Cognitive Behavioral Therapy
n=52 participants at risk
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
|---|---|---|
|
Psychiatric disorders
Mania
|
0.00%
0/53
|
1.9%
1/52 • Number of events 1
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/53
|
1.9%
1/52 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.9%
1/53 • Number of events 1
|
0.00%
0/52
|
|
Injury, poisoning and procedural complications
Head injury
|
1.9%
1/53 • Number of events 1
|
0.00%
0/52
|
Other adverse events
| Measure |
Bupropion + Cognitive Behavioral Therapy
n=53 participants at risk
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
|
Placebo + Cognitive Behavioral Therapy
n=52 participants at risk
Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
4/53
|
1.9%
1/52
|
|
Psychiatric disorders
Anger
|
7.5%
4/53
|
0.00%
0/52
|
|
Psychiatric disorders
Anxiety
|
13.2%
7/53
|
9.6%
5/52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.1%
8/53
|
9.6%
5/52
|
|
General disorders
Decreased appetite
|
13.2%
7/53
|
9.6%
5/52
|
|
Psychiatric disorders
Depression
|
17.0%
9/53
|
19.2%
10/52
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53
|
5.8%
3/52
|
|
General disorders
Elevated blood pressure
|
13.2%
7/53
|
9.6%
5/52
|
|
General disorders
Elevated pulse
|
39.6%
21/53
|
25.0%
13/52
|
|
General disorders
Headache
|
22.6%
12/53
|
26.9%
14/52
|
|
General disorders
Insomnia
|
13.2%
7/53
|
19.2%
10/52
|
|
Nervous system disorders
Irritability
|
13.2%
7/53
|
19.2%
10/52
|
|
General disorders
Low blood pressure
|
5.7%
3/53
|
5.8%
3/52
|
|
General disorders
Low pulse
|
5.7%
3/53
|
9.6%
5/52
|
|
General disorders
Migraine
|
7.5%
4/53
|
3.8%
2/52
|
|
Musculoskeletal and connective tissue disorders
Muscle pain/soreness
|
18.9%
10/53
|
17.3%
9/52
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53
|
7.7%
4/52
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
4/53
|
5.8%
3/52
|
|
Gastrointestinal disorders
Stomache ache
|
15.1%
8/53
|
11.5%
6/52
|
|
Gastrointestinal disorders
Vomited
|
13.2%
7/53
|
13.5%
7/52
|
|
General disorders
Weight gain
|
26.4%
14/53
|
36.5%
19/52
|
|
General disorders
Weight loss
|
28.3%
15/53
|
26.9%
14/52
|
|
General disorders
Worse headache
|
0.00%
0/53
|
5.8%
3/52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place