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New Approaches to Smoking Cessation in Heavy Drinkers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

New Approaches to Smoking Cessation in Heavy Drinkers

NCT02151591•Yale University

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. are at least 18 years of age;
•2. 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
•3. are interested in quitting smoking;
•4. understand English;
•5. 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

•1. 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;
•2. are currently enrolled in alcohol treatment;
•3. meet criteria for drug dependence in the past 12 months; with the exception of marijuana dependence
•4. 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;
•5. report current suicidality (past 12 months), or report suicide attempts within the past 10 years, assessed with the Columbia Suicide Severity Rating Scale;
•6. exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
+14 more criteria

Locations (1)

Yale University School of Medicine

New Haven, Connecticut, United States

Key Dates

Start Date

March 1, 2017

Primary Completion Date

June 1, 2018

Completion Date

August 1, 2018

Last Updated

February 24, 2020

Enrollment

ACTUAL participants

Conditions

Nicotine DependenceCigarette SmokingAlcohol ConsumptionHeavy Drinking

Interventions

Varenicline

DRUG

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

NCT01036581

Drug AbuseNicotine Dependence

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RECRUITINGNA

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

NCT06372899

E-cigarette UseCigarette Smoking+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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New Approaches to Smoking Cessation in Heavy Drinkers

Inclusion Criteria

Exclusion Criteria

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