Trial Outcomes & Findings for New Approaches to Smoking Cessation in Heavy Drinkers (NCT NCT02151591)

NCT ID: NCT02151591

Last Updated: 2020-02-24

Results Overview

Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 26 participants
• Primary outcome timeframe: 6 months post treatment start
• Results posted on: 2020-02-24

Participant Flow

Participant milestones

Measure	Integrated Counseling for Tobacco and Alcohol (INT) Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day	Standard Care for Primary Presenting Concern (SC) Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Overall Study STARTED	13	13
Overall Study COMPLETED	7	10
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Measure	Integrated Counseling for Tobacco and Alcohol (INT) Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day	Standard Care for Primary Presenting Concern (SC) Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Overall Study Lost to Follow-up	6	3

Baseline Characteristics

New Approaches to Smoking Cessation in Heavy Drinkers

Baseline characteristics by cohort

Measure	Integrated Counseling for Tobacco and Alcohol (INT) n=13 Participants Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day	Standard Care for Primary Presenting Concern (SC) n=13 Participants Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day	Total n=26 Participants Total of all reporting groups
Age, Continuous	39.00 age STANDARD_DEVIATION 10.59 • n=5 Participants	42.62 age STANDARD_DEVIATION 13.23 • n=7 Participants	40.81 age STANDARD_DEVIATION 11.87 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post treatment start

Population: Number of participants with smoking abstinence at 6 months

Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion.

Outcome measures

Measure	Integrated Counseling for Tobacco and Alcohol (INT) n=13 Participants Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day	Standard Care for Primary Presenting Concern (SC) n=13 Participants Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Number of Participants With Smoking Abstinence at 6 Months	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 months post treatment start

Log transformed percentage of heavy drinking days 6 months post treatment start.

Outcome measures

Measure	Integrated Counseling for Tobacco and Alcohol (INT) n=13 Participants Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day	Standard Care for Primary Presenting Concern (SC) n=13 Participants Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Log Transformed Percentage of Heavy Drinking Days	2.06 Mean log transformed percentage score Standard Error 0.40	1.45 Mean log transformed percentage score Standard Error 0.38

SECONDARY outcome

Timeframe: 12 weeks

Population: Number of participants who completed treatment.

To assess feasibility/acceptability, the number of participants who completed treatment will be assessed.

Outcome measures

Measure	Integrated Counseling for Tobacco and Alcohol (INT) n=13 Participants Integrated counseling for smoking and alcohol entails weekly counseling for 12-weeks targeting both behaviors. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day	Standard Care for Primary Presenting Concern (SC) n=13 Participants Standard care (SC) for primary presenting concern only. For those presenting with the primary concern of tobacco, standard care will involve weekly smoking counseling alone for 12-weeks. For those presenting with the primary concern of alcohol, standard care will involve weekly alcohol counseling alone. Participants in this condition will also receive 12 weeks of varenicline (Chantix). Varenicline: 12-weeks of treatment. Dose will be titrated as follows: Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Number of Participants Who Completed Treatment.	7 Participants	10 Participants

Adverse Events

Integrated Counseling for Tobacco and Alcohol (INT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care for Primary Presenting Concern (SC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lisa Fucito

YALE UNIVERSITY SCHOOL OF MEDICINE

Phone: 203-200-1470

Email: Lisa.fucito@yale.edu

Results disclosure agreements

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