Trial Outcomes & Findings for Chantix & Bupropion for Smoking Cessation (NCT NCT00587769)

NCT ID: NCT00587769

Last Updated: 2013-04-24

Results Overview

Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 38 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2013-04-24

Participant Flow

Patient's were recruited between 10 September, 2007 and 25 October, 2007 in the community surrounding the Mayo Clinic in Rochester Minnesota.

Patients were excluded for not meeting entry criteria

Participant milestones

Measure	Medication Arm Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chantix & Bupropion for Smoking Cessation

Baseline characteristics by cohort

Measure	Medication Arm n=38 Participants Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
Age Continuous	49.1 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Cigarettes per day	19.9 cigarettes per day STANDARD_DEVIATION 7.8 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations

Outcome measures

Measure	Medication Arm n=38 Participants Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks	27 Participants Interval 54.0 to 85.0

SECONDARY outcome

Timeframe: 6 months

Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations

Outcome measures

Measure	Medication Arm n=38 Participants Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months	22 Participants

Adverse Events

Medication Arm

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Medication Arm n=38 participants at risk Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
Nervous system disorders Sleep disturbance	26.3% 10/38 • Number of events 10 • 6 months
Nervous system disorders Nausea	23.7% 9/38 • Number of events 9 • 6 months
Nervous system disorders Insomnia	15.8% 6/38 • Number of events 6 • 6 months
Nervous system disorders Dizziness	13.2% 5/38 • Number of events 5 • 6 months
Nervous system disorders Vivid dreams	10.5% 4/38 • Number of events 4 • 6 months
Gastrointestinal disorders Constipation	7.9% 3/38 • Number of events 3 • 6 months
Nervous system disorders Dry mouth	7.9% 3/38 • Number of events 3 • 6 months

Additional Information

Jon O. Ebbert

Mayo Clinic

Phone: 507-284-2511

Email: ebbert.jon@mayo.edu

Results disclosure agreements

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