Trial Outcomes & Findings for Bupropion SR Plus Counseling for Smoking Cessation (NCT NCT01621009)

NCT ID: NCT01621009

Last Updated: 2016-01-27

Results Overview

No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 463 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-01-27

Participant Flow

Participants recruited from Madison, WI area through TV, radio, newspaper advertisements from January, 2001 to October 2002

Participants were 1) phone screened, 2) invited to group orientation where signed consent was obtained, and 3) completed CO testing and office visit for physical exam. Participants were considered enrolled after passing all 3 steps and randomization occurred at enrollment.

Participant milestones

Measure	Active Bupropion + Counseling Active bupropion SR plus eight 10-minute individual counseling sessions.	Active Bupropion , No Counseling Active bupropion, No counseling, only medication checks	Placebo Medication + Counseling Placebo bupropion plus eight 10-minute individual counseling sessions	Placebo Medication, No Counseling Placebo bupropion, No counseling, just medication checks
Overall Study STARTED	113	116	121	113
Overall Study COMPLETED	70	65	58	60
Overall Study NOT COMPLETED	43	51	63	53

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion SR Plus Counseling for Smoking Cessation

Baseline characteristics by cohort

Measure	Active Bupropion + Counseling n=113 Participants Active bupropion SR plus eight 10-minute individual counseling sessions.	Active Bupropion , No Counseling n=116 Participants Active bupropion, No counseling, only medication checks	Placebo Medication + Counseling n=121 Participants Placebo bupropion plus eight 10-minute individual counseling sessions	Placebo Medication, No Counseling n=113 Participants Placebo bupropion, No counseling, just medication checks	Total n=463 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants	116 Participants n=7 Participants	121 Participants n=5 Participants	113 Participants n=4 Participants	463 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	36.76 years STANDARD_DEVIATION 11.39 • n=5 Participants	41.03 years STANDARD_DEVIATION 12.64 • n=7 Participants	37.82 years STANDARD_DEVIATION 12.82 • n=5 Participants	39.42 years STANDARD_DEVIATION 11.34 • n=4 Participants	38.76 years STANDARD_DEVIATION 12.16 • n=21 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	57 Participants n=7 Participants	63 Participants n=5 Participants	61 Participants n=4 Participants	233 Participants n=21 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	59 Participants n=7 Participants	58 Participants n=5 Participants	52 Participants n=4 Participants	230 Participants n=21 Participants
Region of Enrollment United States	113 participants n=5 Participants	116 participants n=7 Participants	121 participants n=5 Participants	113 participants n=4 Participants	463 participants n=21 Participants
7-day point prevalence abstinence Abstinent	21 participants n=5 Participants	16 participants n=7 Participants	15 participants n=5 Participants	14 participants n=4 Participants	66 participants n=21 Participants
7-day point prevalence abstinence Not Abstinent	92 participants n=5 Participants	100 participants n=7 Participants	106 participants n=5 Participants	99 participants n=4 Participants	397 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Full intent-to-treat sample

No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.

Outcome measures

Measure	Bupropion + Counseling n=113 Participants Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions	Bupropion, No Counseling n=116 Participants Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.	Placebo + Counseling n=121 Participants : Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date. Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions	Placebo, No Counseling n=113 Participants : Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.
7-day Point Prevalence Abstinence From Smoking at 6 Months	21 Number of abstinent participants	16 Number of abstinent participants	15 Number of abstinent participants	14 Number of abstinent participants

Adverse Events

Placebo Medication

Serious events: 0 serious events

Other events: 66 other events

Deaths: 0 deaths

Active Medication

Serious events: 0 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Medication n=234 participants at risk Medications: Pre-quit - one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date.	Active Medication n=229 participants at risk Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	9.0% 21/234 • Number of events 21 • 6 months	8.3% 19/229 • Number of events 19 • 6 months
Nervous system disorders depression	10.7% 25/234 • Number of events 25 • 6 months	6.6% 15/229 • Number of events 15 • 6 months
Nervous system disorders insomnia	4.3% 10/234 • Number of events 10 • 6 months	15.3% 35/229 • Number of events 35 • 6 months
Nervous system disorders Headache	2.1% 5/234 • Number of events 5 • 6 months	6.1% 14/229 • Number of events 14 • 6 months
Psychiatric disorders Feeling jittery	2.1% 5/234 • Number of events 5 • 6 months	4.8% 11/229 • Number of events 11 • 6 months

Additional Information

Timothy Baker, PhD, Director of Research

University of Wisconsin Center for Tobacco Research and Intervention

Phone: (608) 262-7568

Email: tbb@ctri.wisc.edu

Results disclosure agreements

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