New Approaches to Smoking Cessation in Heavy Drinkers

NCT02151591 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 1106008673K23AA020000-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Cigarette Smoking; Alcohol Consumption; Heavy Drinking

Keywords

Quit smoking; Quit drinking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Log Transformed Percentage of Heavy Drinking Days

  6 months post treatment start

• Number of Participants Who Completed Treatment.

  12 weeks

Study Arms (2)

Integrated Counseling for Tobacco and Alcohol (INT)

EXPERIMENTAL

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

Standard Care for Primary Presenting Concern (SC)

OTHER

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

Interventions

Varenicline DRUG

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

Also known as: Chantix

Integrated Counseling for Tobacco and Alcohol (INT); Standard Care for Primary Presenting Concern (SC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: based on self-reported gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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;

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Alcohol Drinking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Drinking Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Lisa Fucito
• Organization: YALE UNIVERSITY SCHOOL OF MEDICINE

Lisa.fucito@yale.edu

203-200-1470

Study Officials

• Lisa Fucito, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: March 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 24, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available upon final publication of the primary paper.
• Access Criteria: Upon request to PI

Locations

US (1)