Trial Outcomes & Findings for Varenicline and Motivational Advice for Smokers With Substance Use Disorders (NCT NCT00756275)

NCT ID: NCT00756275

Last Updated: 2018-08-27

Results Overview

7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 158 participants
• Primary outcome timeframe: 3 month follow up
• Results posted on: 2018-08-27

Participant Flow

Five individuals enrolled were found to not meet study criteria, 3 did not pass the medical screen, and 13 individuals were lost prior to being randomized.

Participant milestones

Measure	Nicotine Replacement + PLA Pill Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use: 21mg/day for 4 weeks, 14mg/day for 4 weeks, 7mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch Varenicline plus matched placebo patches containing no nicotine varenicline: Varenicline (VAR, 2mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Overall Study STARTED	60	77
Overall Study COMPLETED	31	49
Overall Study NOT COMPLETED	29	28

Reasons for withdrawal

Measure	Nicotine Replacement + PLA Pill Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use: 21mg/day for 4 weeks, 14mg/day for 4 weeks, 7mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch Varenicline plus matched placebo patches containing no nicotine varenicline: Varenicline (VAR, 2mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Overall Study Lost to Follow-up	25	21
Overall Study Withdrawal by Subject	4	7

Baseline Characteristics

Varenicline and Motivational Advice for Smokers With Substance Use Disorders

Baseline characteristics by cohort

Measure	Nicotine Replacement + PLA Pill n=60 Participants Nicotine Replacement Treatment (NRT): Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3	Varenicline + PLA Patch n=77 Participants varenicline: Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day. Pl	Total n=137 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
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	77 Participants n=7 Participants	137 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.20 years STANDARD_DEVIATION 9.7 • n=5 Participants	39.96 years STANDARD_DEVIATION 10.51 • n=7 Participants	39.6 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	38 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	39 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	77 participants n=7 Participants	137 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 month follow up

Population: "Intent to Treat" Note: People who were lost were counted as smoked

7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=60 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=77 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
7-day Point-prevalence Smoking Abstinence	2 participants	10 participants

PRIMARY outcome

Timeframe: 6 month follow up

7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=60 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=77 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
7-day Point-prevalence Smoking Abstinence	2 participants	7 participants

SECONDARY outcome

Timeframe: Weeks 9 to 12

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=60 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=77 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Length of Longest Continuous Abstinence	6.25 Days Standard Deviation 10.06	7.84 Days Standard Deviation 11.39

SECONDARY outcome

Timeframe: 3 month follow up

Population: Outcome data available for 89 participants who completed 3 month follow up.

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=37 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=52 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Percent Smoking Days	62.39 percentage of days Standard Deviation 38.84	70.37 percentage of days Standard Deviation 38.79

SECONDARY outcome

Timeframe: 6 month follow up

Population: Outcome data available for 80 participants who completed 6 month follow up.

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=31 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=49 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Percent Smoking Days	84.52 percentage of days Standard Deviation 31.25	77.12 percentage of days Standard Deviation 37.61

SECONDARY outcome

Timeframe: 3 month follow up

Population: Outcome data available for 89 participants who completed 3 month follow up.

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=37 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=52 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Percent Relapsed to Drug Use	12 percentage of participants	14 percentage of participants

SECONDARY outcome

Timeframe: 6 month follow up

Population: Outcome data available for 80 participants who completed 6 month follow up.

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=31 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=49 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Percent Relapsed to Drug Use	8 percentage of participants	18 percentage of participants

SECONDARY outcome

Timeframe: 3 month follow up

Population: Outcome data available for 89 participants who completed 3 month follow up.

6 or more drinks for men; 5 or more drinks for women

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=37 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=51 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Percent Relapsed to Any Heavy Drinking	7 percentage of participants	9 percentage of participants

SECONDARY outcome

Timeframe: 6 month follow up

Population: Outcome data available for 80 participants who completed 6 month follow up.

6 or more drinks for men; 5 or more drinks for women

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=31 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=49 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Percent Relapsed to Any Heavy Drinking	9 percentage of particpiants	8 percentage of particpiants

SECONDARY outcome

Timeframe: Week 12

Population: Outcome data available for 80 participants who had valid depression data 12 week assessment.

0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression

Outcome measures

Measure	Nicotine Replacement + PLA Pill n=36 Participants Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=44 Participants Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Beck Depression Inventory	5.19 units on a scale Standard Deviation 6.53	5.75 units on a scale Standard Deviation 8.47

Adverse Events

Nicotine Replacement + PLA Pill

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Varenicline + PLA Patch

Serious events: 10 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nicotine Replacement + PLA Pill n=60 participants at risk Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=77 participants at risk Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Psychiatric disorders substance abuse (hospital or death)	1.7% 1/60 • Number of events 1 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.	5.2% 4/77 • Number of events 4 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.
Musculoskeletal and connective tissue disorders accidents (ER or hospital)	1.7% 1/60 • Number of events 1 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.	3.9% 3/77 • Number of events 4 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.
Respiratory, thoracic and mediastinal disorders hospital and respiratory disorder	1.7% 1/60 • Number of events 7 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.	0.00% 0/77 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.
Reproductive system and breast disorders pregnancy complication	0.00% 0/60 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.	1.3% 1/77 • Number of events 1 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.
Endocrine disorders diabetic complication	0.00% 0/60 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.	1.3% 1/77 • Number of events 1 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.
Nervous system disorders disorientation	0.00% 0/60 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.	1.3% 1/77 • Number of events 1 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.

Other adverse events

Measure	Nicotine Replacement + PLA Pill n=60 participants at risk Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.	Varenicline + PLA Patch n=77 participants at risk Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day.
Psychiatric disorders increased depression	5.0% 3/60 • Number of events 3 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.	1.3% 1/77 • Number of events 1 Structured interviews weekly for 12 weeks and at 3 \& 6 months and as reported any time by participant or clinical staff member.

Additional Information

Damaris Rohsenow, PhD

Brown University

Phone: 401-863-6665

Email: Damaris_Rohsenow@brown.edu

Results disclosure agreements

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