Trial Outcomes & Findings for An Open Label Trial of Bupropion and Naltrexone for Binge Drinking (NCT NCT02842073)

NCT ID: NCT02842073

Last Updated: 2018-12-26

Results Overview

Tolerability assessed by specifically probing for intervention-associated adverse effects.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-12-26

Participant Flow

Participant milestones

Measure	Naltrexone and Buproprion Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Naltrexone and Buproprion Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

Baseline characteristics by cohort

Measure	Naltrexone and Buproprion n=12 Participants Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Age, Continuous	33.1 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants
Number of Binge Drinking Days in 90 days prior to screening	17.3 days STANDARD_DEVIATION 7.8 • n=5 Participants
Intensity of Binge Drinking prior to Study	8.4 drinks/binge drinking day STANDARD_DEVIATION 1.0 • n=5 Participants
Craving for Alcohol	11.25 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Tolerability assessed by specifically probing for intervention-associated adverse effects.

Outcome measures

Measure	Naltrexone and Buproprion n=12 Participants Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Number of Participants With Treatment-Associated Adverse Events Headache	5 Participants
Number of Participants With Treatment-Associated Adverse Events Insomnia	2 Participants
Number of Participants With Treatment-Associated Adverse Events Dizziness	2 Participants

PRIMARY outcome

Timeframe: Throughout study, a total of approximately 12 weeks

Retention was evaluated indirectly by accounting for those participants who discontinued either naltrexone or bupropion or study participation itself due to intolerance.

Outcome measures

Measure	Naltrexone and Buproprion n=12 Participants Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Number of Participants Discontinuing Subsequent to Defined Intolerance Discontinued: Naltrexone	3 Participants
Number of Participants Discontinuing Subsequent to Defined Intolerance Discontinued: Buproprion	1 Participants
Number of Participants Discontinuing Subsequent to Defined Intolerance Discontinued: Study	1 Participants

PRIMARY outcome

Timeframe: 12 weeks

The number of binge drinking days during treatment with bupropion + naltrexone

Outcome measures

Measure	Naltrexone and Buproprion n=12 Participants Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Number of Binge Drinking Days During Treatment	3.2 days Standard Deviation 2.9

SECONDARY outcome

Timeframe: 12 weeks

Craving for alcohol will be assessed using the Penn Alcohol Craving Scale (PACS) The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6 with the highest possible total score of 30. Higher scores reflect a higher level of craving. This outcome measure is the final PACS total score obtained in the trial.

Outcome measures

Measure	Naltrexone and Buproprion n=12 Participants Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Final Penn Alcohol Craving Scale (PACS) Score	4.4 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Naltrexone and Buproprion n=12 Participants Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Mean Number of Drinks/Binge Drinking Day During Treatment	3.3 drinks/binge drinking day Standard Deviation 0.9

Adverse Events

Naltrexone and Buproprion

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Naltrexone and Buproprion n=12 participants at risk Bupropion XL 150 mg/d on Days 1-4 increased to 300 mg/d for Days 5-84. Naltrexone 25 mg/d from Days 7-9 and increased to 50 mg/d for Days 10-84.
Nervous system disorders Headache	41.7% 5/12 • Number of events 5 • Throughout the 12-week study period.
Nervous system disorders Insomnia	16.7% 2/12 • Number of events 2 • Throughout the 12-week study period.
Nervous system disorders Dizziness	16.7% 2/12 • Number of events 2 • Throughout the 12-week study period.
General disorders Low energy	16.7% 2/12 • Number of events 2 • Throughout the 12-week study period.
General disorders Reduced Appetite	8.3% 1/12 • Number of events 1 • Throughout the 12-week study period.
General disorders Dry Mouth	8.3% 1/12 • Number of events 1 • Throughout the 12-week study period.
Gastrointestinal disorders Constipation	25.0% 3/12 • Number of events 3 • Throughout the 12-week study period.
Gastrointestinal disorders Nausea	16.7% 2/12 • Number of events 2 • Throughout the 12-week study period.
Nervous system disorders Irritability	25.0% 3/12 • Number of events 3 • Throughout the 12-week study period.

Additional Information

James C Garbutt, MD

University of North Carolina at Chapel Hill

Phone: 984-974-2201

Email: jc_garbutt@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place