Trial Outcomes & Findings for Improving Smoking Cessation Outcomes in Heavy Drinkers - 1 (NCT NCT00107575)

NCT ID: NCT00107575

Last Updated: 2016-10-26

Results Overview

7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 236 participants
• Primary outcome timeframe: 26 weeks
• Results posted on: 2016-10-26

Participant Flow

Participant milestones

Measure	Standard Treatment Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Overall Study STARTED	119	117
Overall Study COMPLETED	108	107
Overall Study NOT COMPLETED	11	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

Baseline characteristics by cohort

Measure	Standard Treatment n=119 Participants Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) n=117 Participants Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention	Total n=236 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants	112 Participants n=7 Participants	225 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	40.6 years STANDARD_DEVIATION 12.1 • n=5 Participants	42.3 years STANDARD_DEVIATION 11.8 • n=7 Participants	41.5 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	64 Participants n=7 Participants	130 Participants n=5 Participants
Region of Enrollment United States	119 participants n=5 Participants	117 participants n=7 Participants	236 participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

Population: For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period.

7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt

Outcome measures

Measure	Standard Treatment n=119 Participants Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) n=115 Participants Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Smoking Abstinence at 26 Weeks	21 participants	22 participants

PRIMARY outcome

Timeframe: 16 weeks

7 days of smoking abstinence confirmed biochemically at 16 weeks

Outcome measures

Measure	Standard Treatment n=119 Participants Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) n=117 Participants Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Smoking Abstinence at 16 Weeks	21 Participants	21 Participants

PRIMARY outcome

Timeframe: 8 weeks

7 days of smoking abstinence confirmed biochemically at 8 weeks

Outcome measures

Measure	Standard Treatment n=119 Participants Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) n=117 Participants Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Smoking Abstinence at 8 Weeks	37 Participants	46 Participants

PRIMARY outcome

Timeframe: 2 weeks

7 days of smoking abstinence confirmed biochemically at 2 weeks

Outcome measures

Measure	Standard Treatment n=119 Participants Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) n=117 Participants Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Smoking Abstinence at 2 Weeks	54 Participants	67 Participants

SECONDARY outcome

Timeframe: At 2, 8, 16, and 26-week follow-ups

Population: The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview

Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor.

Outcome measures

Measure	Standard Treatment n=106 Participants Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) n=110 Participants Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 3-4	10.3 drinks Standard Deviation 10.4	8.4 drinks Standard Deviation 10.8
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 5-6	10.3 drinks Standard Deviation 10.9	9.1 drinks Standard Deviation 11.1
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 19-20	10.8 drinks Standard Deviation 10.3	9.8 drinks Standard Deviation 11.8
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 21-22	10.1 drinks Standard Deviation 9.3	9.1 drinks Standard Deviation 11.2
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 23-24	9.8 drinks Standard Deviation 8.6	9.1 drinks Standard Deviation 12.0
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 25-26	10.9 drinks Standard Deviation 9.9	10.0 drinks Standard Deviation 13.3
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 1-2	9.8 drinks Standard Deviation 10.0	8.2 drinks Standard Deviation 9.9
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 7-8	10.7 drinks Standard Deviation 10.7	9.6 drinks Standard Deviation 11.2
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 9-10	10.1 drinks Standard Deviation 9.7	9.1 drinks Standard Deviation 9.8
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 11-12	9.5 drinks Standard Deviation 9.8	9.2 drinks Standard Deviation 10.3
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 13-14	10.5 drinks Standard Deviation 11.2	8.6 drinks Standard Deviation 9.1
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 15-16	10.6 drinks Standard Deviation 11.0	9.2 drinks Standard Deviation 9.6
Alcohol Drinks Consumed Per Week Over a 2-week Period Drinks per week: Weeks 17-18	10.9 drinks Standard Deviation 10.3	9.0 drinks Standard Deviation 10.3

Adverse Events

Standard Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Treatment n=119 participants at risk Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch	Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) n=117 participants at risk Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
General disorders Death	0.00% 0/119 • 6 months	1.7% 2/117 • 6 months
Respiratory, thoracic and mediastinal disorders Lung Cancer	0.00% 0/119 • 6 months	0.85% 1/117 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Christopher Kahler

Brown University

Phone: (401) 863-6651

Email: Christopher_Kahler@brown.edu

Results disclosure agreements

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