Trial Outcomes & Findings for Bupropion in Helping Adults Stop Smoking (NCT NCT00534001)

NCT ID: NCT00534001

Last Updated: 2017-05-30

Results Overview

Prequit Change in Cigarettes Per Day

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 95 participants
• Primary outcome timeframe: 3-Week PreQuit Drug Manipulation Phase
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	1-week Run In (Standard)	4-week Run-in (Extended)
Overall Study STARTED	48	47
Overall Study COMPLETED	43	43
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion in Helping Adults Stop Smoking

Baseline characteristics by cohort

Measure	Arm I (1-week run-in) n=48 Participants Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally placebo: Given orally	Arm II (4-week run-in) n=47 Participants Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally	Total n=95 Participants Total of all reporting groups
Age, Continuous	46.7 years STANDARD_DEVIATION 9.3 • n=5 Participants	45.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	46 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Racial/Ethnic Minority	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White/Not Hispanic	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Cigarettes Smoked Per Day (CPD)	22.0 CPD STANDARD_DEVIATION 6.0 • n=5 Participants	23.4 CPD STANDARD_DEVIATION 7.9 • n=7 Participants	23 CPD STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: 3-Week PreQuit Drug Manipulation Phase

Population: Excludes participants with missing data (2 in Arm 1, 3 in Arm 2)

Prequit Change in Cigarettes Per Day

Outcome measures

Measure	Arm I (1-week run-in) n=46 Participants Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally placebo: Given orally	Arm II (4-week run-in) n=46 Participants Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally
Prequit Change in Cigarettes Per Day	-2.6 Cigarettes Per Day Standard Error 0.5	-3.9 Cigarettes Per Day Standard Error 0.6

SECONDARY outcome

Timeframe: 4 weeks

Bioverified 4-week continuous abstinence

Outcome measures

Measure	Arm I (1-week run-in) n=48 Participants Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally placebo: Given orally	Arm II (4-week run-in) n=47 Participants Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally
Abstinence	25 Participants	15 Participants

Adverse Events

Arm I (1-week run-in)

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Arm II (4-week run-in)

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm I (1-week run-in) n=48 participants at risk Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally placebo: Given orally	Arm II (4-week run-in) n=47 participants at risk Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally
General disorders Any Non-Serious Adverse Event	100.0% 48/48 • Number of events 48 • 8 weeks Only participant-volunteered side effects were noted.	100.0% 47/47 • Number of events 47 • 8 weeks Only participant-volunteered side effects were noted.

Additional Information

Martin Mahoney

Roswell Park Cancer Institute

Phone: 716-845-2300

Email: martin.mahoney@roswellpark.org

Results disclosure agreements

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