New Approaches to Smoking Cessation in Heavy Drinkers

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption; Nicotine Dependence; Cigarette Smoking; Heavy Drinking
• Intervention / Treatment: Drug: Varenicline

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

   • any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin);
   • clinically significant, unstable cardiovascular disease/uncontrolled hypertension;
   • hepatic or renal impairment;
   • severe obstructive pulmonary disease;
   • diabetes mellitus requiring insulin or certain oral medications (i.e., sulfonylureas) and an A1C hemoglobin test score of > 7 for participants not prescribed these medications;
   • baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg;
7. are cognitively impaired;
8. are unable to read/understand English;
9. are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide);
10. report new onset of psychiatric disorders or new psychotropic medications within the past 3 months, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months or who report occasional use of prescription sleep aids that they are willing to discontinue;
11. have used another investigational drug within 30 days or have used medications to treat alcohol (e.g., naltrexone, topiramate, acamprosate, disulfiram) or nicotine use (e.g., clonidine, varenicline, bupropion, nicotine replacement) in the past 3 months or intend to use these medications; (prior use of nicotine replacement in situations where smoking is not permitted (e.g., planes) without the intention to quit smoking is not exclusionary at screening)
12. intend to donate blood or blood products during the treatment phase of the study;
13. have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin);
14. have a history of serious hypersensitivity reactions or skin reactions to varenicline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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; Other Names: Chantix
Other: 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).	Drug: 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; Other Names: Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months post treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log Transformed Percentage of Heavy Drinking Days	Log transformed percentage of heavy drinking days 6 months post treatment start.	6 months post treatment start
Number of Participants Who Completed Treatment.	To assess feasibility/acceptability, the number of participants who completed treatment will be assessed.	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Lisa Fucito, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Quit smoking; Quit drinking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Tobacco Use Disorder; Alcoholic Intoxication; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 1106008673; K23AA020000-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: A de-identified dataset will be made available to researchers who request data from the PI
• IPD Sharing Time Frame: The data will be available upon final publication of the primary paper.
• IPD Sharing Access Criteria: Upon request to PI
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No