Trial Outcomes & Findings for Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence (NCT NCT00304707)

NCT ID: NCT00304707

Last Updated: 2017-05-15

Results Overview

The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 143 participants
• Primary outcome timeframe: week 7, week 11 and week 24 after scheduled quit day
• Results posted on: 2017-05-15

Participant Flow

Participant milestones

Measure	Bupropion 300-mg Capsules participants in this arm receive bupropion Bupropion: 300 mg QD	Placebo placebo placebo: placebo
Overall Study STARTED	73	70
Overall Study COMPLETED	66	64
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

Baseline characteristics by cohort

Measure	Bupropion 300-mg Capsules n=73 Participants participants in this arm receive bupropion Bupropion: 300 mg QD	Placebo n=70 Participants placebo placebo: placebo	Total n=143 Participants Total of all reporting groups
Age, Continuous	49.2 years STANDARD_DEVIATION 7.5 • n=5 Participants	47.8 years STANDARD_DEVIATION 10.5 • n=7 Participants	48.6 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants	54 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (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	73 participants n=5 Participants	70 participants n=7 Participants	143 participants n=5 Participants

PRIMARY outcome

Timeframe: week 7, week 11 and week 24 after scheduled quit day

The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.

Outcome measures

Measure	Bupropion 300-mg Capsules n=73 Participants participants in this arm receive bupropion Bupropion: 300 mg QD	Placebo n=70 Participants placebo placebo: placebo
Smoking Abstinence week 7	19 participants	21 participants
Smoking Abstinence week 11	12 participants	9 participants
Smoking Abstinence week 24	6 participants	11 participants

Adverse Events

Bupropion 300-mg Capsules

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bupropion 300-mg Capsules n=73 participants at risk participants in this arm receive bupropion Bupropion: 300 mg QD	Placebo n=70 participants at risk placebo placebo: placebo
Nervous system disorders insomnia	6.8% 5/73	2.9% 2/70
Endocrine disorders Dry mouth	2.7% 2/73	1.4% 1/70
Cardiac disorders Rise in systolic blood pressure	0.00% 0/73	1.4% 1/70

Additional Information

David Kalman, PhD

University of Massachusetts Medical School

Phone: 9785782371

Email: kalmand@comcast.net

Results disclosure agreements

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