New Approaches to Smoking Cessation in Heavy Drinkers
Overview
- Phase
- Phase 1
- Intervention
- Varenicline
- Conditions
- Nicotine Dependence
- Sponsor
- Yale University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Number of Participants With Smoking Abstinence at 6 Months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to develop and test an integrated cognitive-behavioral intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot phase will be used to refine this protocol for the subsequent randomized, controlled pilot phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a 12-week treatment phase in which participants receive varenicline (Chantix) and weekly, personalized counseling.
Detailed Description
The purpose of the proposed project is to develop and test a 12-week integrated cognitive-behavioral therapy (CBT) intervention for smoking and alcohol (SA) + varenicline (Chantix) among heavy drinking smokers (i.e., CBT for SA). The project involves two phases. In Phase 1, an open-label pre-pilot study of CBT for SA will be conducted with 10 heavy drinking smokers. The primary results of this phase will be used to refine the CBT for SA protocol. In Phase 2, a randomized, controlled pilot study will be conducted with 40 heavy drinking smokers comparing CBT for SA with standard smoking counseling (SC). All participants in the randomized pilot study will also receive varenicline (Chantix). Primary and Study Completion dates were changed 6/2016 to reflect an additional year added year to the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •are at least 18 years of age;
- •report smoking 100 cigarettes over lifetime and currently smoke at least twice weekly on average in the past 90 days and have a urinary cotinine level of \>=30ng/mL by semi-quantitative analysis, and/or \>= 2 on a NicAlert dipstick
- •are interested in quitting smoking;
- •understand English;
- •exceed National Institute on Alcohol Abuse and Alcoholism heavy drinking criteria (i.e., for men, \>14 drinks/week or 5 drinks/day at least once per month over the past 12 months; for women, \>7 drinks/week or \>4 drinks/day at least once per month over the past 12 months.
Exclusion Criteria
- •meet criteria for alcohol dependence in the past 12 months that is clinically severe defined by
- •a history of seizures, delirium, or hallucinations during alcohol withdrawal;
- •a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of \> 8;
- •report drinking to avoid withdrawal symptoms, or d) have had prior treatment of withdrawal;
- •have required medical treatment of alcohol withdrawal within the past 6 months;
- •are currently enrolled in alcohol treatment;
- •meet criteria for drug dependence in the past 12 months; with the exception of marijuana dependence
- •exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder, organic mood or mental disorders by history or psychological examination;
- •report current suicidality (past 12 months), or report suicide attempts within the past 10 years, assessed with the Columbia Suicide Severity Rating Scale;
- •exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
Arms & Interventions
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).
Intervention: Varenicline
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).
Intervention: Varenicline
Outcomes
Primary Outcomes
Number of Participants With Smoking Abstinence at 6 Months
Time Frame: 6 months post treatment start
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.
Secondary Outcomes
- Number of Participants Who Completed Treatment.(12 weeks)
- Log Transformed Percentage of Heavy Drinking Days(6 months post treatment start)