Trial Outcomes & Findings for Buproprion for Binge Drinking (NCT NCT03169244)
NCT ID: NCT03169244
Last Updated: 2020-08-26
Results Overview
Frequency is assessed as number of binge episodes/time in trial controlling for missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Randomization (Week 0) to Week 12
Results posted on
2020-08-26
Participant Flow
Participant milestones
| Measure |
Bupropion XL
Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
|
Placebo
Placebo will be initiated on Day 1 and continue throughout the course of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
Randomly Assigned
|
22
|
20
|
|
Overall Study
Received Intervention
|
22
|
18
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Bupropion XL
Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
|
Placebo
Placebo will be initiated on Day 1 and continue throughout the course of the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Data missing for two participants
Baseline characteristics by cohort
| Measure |
Bupropion XL
n=22 Participants
Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
|
Placebo
n=18 Participants
Placebo will be initiated on Day 1 and continue throughout the course of the study.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.2 years
STANDARD_DEVIATION 7.26 • n=22 Participants
|
24.4 years
STANDARD_DEVIATION 3.57 • n=18 Participants
|
25.4 years
STANDARD_DEVIATION 5.89 • n=40 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=22 Participants
|
13 Participants
n=18 Participants
|
28 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=22 Participants
|
5 Participants
n=18 Participants
|
12 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=22 Participants
|
3 Participants
n=18 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=22 Participants
|
15 Participants
n=18 Participants
|
34 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=22 Participants
|
1 Participants
n=18 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=22 Participants
|
1 Participants
n=18 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=22 Participants
|
13 Participants
n=18 Participants
|
27 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
3 Participants
n=18 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
18 Participants
n=18 Participants
|
40 Participants
n=40 Participants
|
|
Marital Status
Married
|
3 Participants
n=22 Participants
|
3 Participants
n=18 Participants
|
6 Participants
n=40 Participants
|
|
Marital Status
Divorced/Separated
|
1 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=40 Participants
|
|
Marital Status
Single, Never Married
|
18 Participants
n=22 Participants
|
15 Participants
n=18 Participants
|
33 Participants
n=40 Participants
|
|
Years Education
|
15.7 years
STANDARD_DEVIATION 2.27 • n=22 Participants
|
16.2 years
STANDARD_DEVIATION 1.48 • n=18 Participants
|
16.0 years
STANDARD_DEVIATION 1.95 • n=40 Participants
|
|
Smoking History
Never Smoked
|
17 Participants
n=20 Participants • Data missing for two participants
|
15 Participants
n=18 Participants • Data missing for two participants
|
32 Participants
n=38 Participants • Data missing for two participants
|
|
Smoking History
Less than or equal to 1/2 Pack/Day
|
2 Participants
n=20 Participants • Data missing for two participants
|
3 Participants
n=18 Participants • Data missing for two participants
|
5 Participants
n=38 Participants • Data missing for two participants
|
|
Smoking History
Greater than or equal to 1 Pack/Day
|
1 Participants
n=20 Participants • Data missing for two participants
|
0 Participants
n=18 Participants • Data missing for two participants
|
1 Participants
n=38 Participants • Data missing for two participants
|
|
Alcohol Use
|
8.6 years
STANDARD_DEVIATION 6.02 • n=22 Participants
|
7.2 years
STANDARD_DEVIATION 3.78 • n=18 Participants
|
8.0 years
STANDARD_DEVIATION 5.12 • n=40 Participants
|
|
Mean Proportion Binge Drinking 90 Days Before Screening
|
0.27 Proportion of Binge Drinking Days
STANDARD_DEVIATION 0.13 • n=22 Participants
|
0.21 Proportion of Binge Drinking Days
STANDARD_DEVIATION 0.09 • n=18 Participants
|
0.24 Proportion of Binge Drinking Days
STANDARD_DEVIATION 0.12 • n=40 Participants
|
|
Intensity per Binge Drinking Episode
|
1.64 unitless
STANDARD_DEVIATION 0.35 • n=22 Participants
|
1.70 unitless
STANDARD_DEVIATION 0.53 • n=18 Participants
|
1.67 unitless
STANDARD_DEVIATION 0.44 • n=40 Participants
|
|
Drinks per Binge Drinking Episode
|
7.02 Drinks per Binge Episode
STANDARD_DEVIATION 1.31 • n=22 Participants
|
7.24 Drinks per Binge Episode
STANDARD_DEVIATION 2.23 • n=18 Participants
|
7.12 Drinks per Binge Episode
STANDARD_DEVIATION 1.76 • n=40 Participants
|
|
Gamma-glutamyltransferase (GGT)
|
29.6 U/L
STANDARD_DEVIATION 23.8 • n=22 Participants
|
25.0 U/L
STANDARD_DEVIATION 17.2 • n=18 Participants
|
27.6 U/L
STANDARD_DEVIATION 21.0 • n=40 Participants
|
PRIMARY outcome
Timeframe: Randomization (Week 0) to Week 12Population: Data unavailable for one placebo participant who did not provide any Timeline Follow Back data (TLFB).
Frequency is assessed as number of binge episodes/time in trial controlling for missing data.
Outcome measures
| Measure |
Bupropion XL
n=22 Participants
Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
|
Placebo
n=17 Participants
Placebo will be initiated on Day 1 and continue throughout the course of the study.
|
|---|---|---|
|
Change in Proportion of Binge Drinking Days
|
-0.13 Binge Drinking Days
Standard Deviation 0.12
|
-0.11 Binge Drinking Days
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Randomization (Week 0) to Week 12Population: Data unavailable for one placebo participant who did not provide any Timeline Follow Back data (TLFB).
Intensity is defined as the number of drinks per binge day scaled by the minimum threshold of a binge episode per gender (4 drinks/day for females; 5 drinks/day for males). Accordingly, if a female consumed 4 drinks in a binge drinking day, the intensity would be 1.0 and a female who consumed 6 drinks in a binge drinking day would have an intensity of 1.5.
Outcome measures
| Measure |
Bupropion XL
n=22 Participants
Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
|
Placebo
n=17 Participants
Placebo will be initiated on Day 1 and continue throughout the course of the study.
|
|---|---|---|
|
Change in the Intensity of Binge Drinking
|
-0.02 unitless
Standard Deviation 0.48
|
-0.09 unitless
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Randomization (Week 0) to Week 12Population: Data unavailable for one placebo participant who did not provide GGT data.
Change in serum Gamma-glutamyltransferase (GGT) levels
Outcome measures
| Measure |
Bupropion XL
n=22 Participants
Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
|
Placebo
n=17 Participants
Placebo will be initiated on Day 1 and continue throughout the course of the study.
|
|---|---|---|
|
Change in GGT
|
12.8 U/L
Standard Deviation 67.3
|
-1.8 U/L
Standard Deviation 9.75
|
Adverse Events
Bupropion XL
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupropion XL
n=22 participants at risk
Bupropion XL (extended release) will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
|
Placebo
n=18 participants at risk
Placebo will be initiated on Day 1 and continue throughout the course of the study.
|
|---|---|---|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 4 • From randomization through study follow-up, a total of approximately 16 weeks
|
44.4%
8/18 • Number of events 9 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
Gastrointestinal disorders
Decreased Appetite
|
13.6%
3/22 • Number of events 3 • From randomization through study follow-up, a total of approximately 16 weeks
|
11.1%
2/18 • Number of events 2 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
18.2%
4/22 • Number of events 4 • From randomization through study follow-up, a total of approximately 16 weeks
|
22.2%
4/18 • Number of events 7 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
5.6%
1/18 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
2/22 • Number of events 2 • From randomization through study follow-up, a total of approximately 16 weeks
|
0.00%
0/18 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.5%
1/22 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
0.00%
0/18 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
General disorders
Insomnia
|
18.2%
4/22 • Number of events 4 • From randomization through study follow-up, a total of approximately 16 weeks
|
5.6%
1/18 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
General disorders
Dry Mouth
|
13.6%
3/22 • Number of events 3 • From randomization through study follow-up, a total of approximately 16 weeks
|
5.6%
1/18 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
General disorders
Sweating
|
4.5%
1/22 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
0.00%
0/18 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
Nervous system disorders
Tremor
|
4.5%
1/22 • Number of events 2 • From randomization through study follow-up, a total of approximately 16 weeks
|
0.00%
0/18 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
0.00%
0/18 • From randomization through study follow-up, a total of approximately 16 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/22 • From randomization through study follow-up, a total of approximately 16 weeks
|
5.6%
1/18 • Number of events 1 • From randomization through study follow-up, a total of approximately 16 weeks
|
Additional Information
James C. Garbutt, MD
University of North Carolina at Chapel Hill
Phone: 919-445-0205
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place