Varenicline Treatment of Alcohol Dependence in Smokers

March 4, 2020 updated by: Yale University

1/2-Multi-site Study: Varenicline Treatment of Alcohol Dependent Smokers

The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Building upon knowledge about the role of nicotinic acetylcholine receptors in alcohol drinking and smoking, varenicline, a smoking cessation treatment that targets these receptors, will be tested as a potential treatment for alcohol dependent smokers seeking alcohol treatment.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Connecticut Mental Health Center - Substance Abuse Treatment Unit
    • New York
      • New York, New York, United States, 10016
        • Parallax Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • are 18 - 70 years of age and seeking treatment of alcohol drinking;
  • meet DSM-IV TR Criteria for Alcohol Dependence
  • report smoking 100 cigarettes or more in their 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 urinalysis or equivalent plasma cotinine level (> 6 ng/mL);
  • report heavy drinking on at least 2 days on average per week (i.e., ≥ 4 drinks on an occasion for women and ≥ 5 drinks for men) for the past 90 days and no more than 7 consecutive days of abstinence at intake.

Exclusion Criteria:

  • 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
  • have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
  • have a history of serious hypersensitivity reactions or skin reactions to varenicline;
  • 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 suicidal ideation (past 6 months) or lifetime hx of suicidal behavior assessed with the Columbia Suicide Severity Rating Scale 60; or risk for aggression using a cut-off of 15 or more on the Overt Aggression Scale - Modified Aggression Scale or 6 or more on the OAS-M Irritability Subscale 61.
  • have used any psychotropic drug in the past month, 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;
  • have a current DSM-IV diagnosis of drug dependence other than nicotine or alcohol

  • are at risk for an alcohol withdrawal syndrome as evidenced by:

    • a history of seizures, delirium, or hallucinations during alcohol withdrawal
    • a Clinical Institute Withdrawal Assessment scale 62 score of > 8,
    • report drinking to avoid withdrawal symptoms
    • have required medical treatment of alcohol withdrawal within the past 6 months
  • 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;
  • intend to donate blood or blood products during the treatment phase of the study
  • have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 39.99 or weight less than 45 kg;
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Sugar pill
Drug: Varenicline
0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Other Names:
  • Chantix
ACTIVE_COMPARATOR: Varenicline
Drug: Varenicline
0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
Other Names:
  • Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Time Frame: weeks 9-12
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
weeks 9-12
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Time Frame: weeks 13-16
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
weeks 13-16
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
Time Frame: 8 weeks
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Abstinence
Time Frame: Weeks 13-16
Smoking abstinence is defined by self-reported abstinence from smoking for the last four weeks of treatment (weeks 13-16) and a urine cotinine level less than 15ng/mL measured at week 17.
Weeks 13-16
Drinking Related Consequences
Time Frame: End of treatment (Week 17)
A self-report measure of negative consequences from drinking will be administered and the total score are analyzed. The ImBIBe, a measure of alcohol consequences based on the Drinker Inventory of Consequences (DRINC) was used. The DRINC total score has a range from 0-45, 45 being the highest score (or greatest number of negative consequences).
End of treatment (Week 17)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Columbia University

Investigators

  • Principal Investigator: Allen Zweben, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1106008598
  • 1R01AA020388-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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