Effect of Varenicline on Reactivity to Smoking and Drinking Cues

September 3, 2015 updated by: Laurie Zawertailo, Centre for Addiction and Mental Health

Effect of Varenicline on Reactivity to Smoking and Drinking Cues in Individuals With Concurrent Tobacco Dependence and Alcohol Use

Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline.

Hypotheses

  1. Two weeks of varenicline treatment will significantly decrease cue-induced tobacco craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2 receptors and its downstream effect on dopamine release).
  2. Varenicline will decrease cue-induced alcohol craving compared to placebo.
  3. The impact of Varenicline on cue-induced alcohol craving will be greater in heavy drinkers compared to social drinkers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The relationship between alcohol and tobacco dependence needs to be addressed as such populations are generally excluded from clinical trials involving smoking cessation pharmacotherapy. Furthermore, the effect of Varenicline(Pfizer Pharmaceuticals)treatment on tobacco cue-induced craving has not been empirically measured, nor has the effect of varenicline on alcohol consumption. In addition to being an effective aid in smoking cessation, preliminary evidence has shown that Varenicline can decrease alcohol consumption in animal models.

Varenicline is a partial agonist of the α4β2 nicotinic acetylcholine receptor. This drug's partial agonist effect allows for the activation of this receptor at a lesser degree than nicotine while simultaneously preventing nicotine binding due to the drugs high affinity (i.e.: antagonist effect) for this receptor subtype.

Varenicline has recently been approved in Canada as an aid for smoking cessation. This study will be a double-blind, placebo-controlled randomized study. It will assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks of treatment with either varenicline or placebo.Ultimately This study may help to further understand the association between smoking and drinking alcohol.

This study will consist of two study groups composed of 40 subjects each being randomized to receive either placebo or varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). One group will be heavy smokers and heavy drinkers while the other will be heavy smokers and social drinkers. Upon entering the study, subjects will undergo baseline cognitive and craving measures for both tobacco and alcohol associated cue presentations prior to randomization to varenicline or placebo. Subjects will be provided a 1-week supply of study medications and directions for use. During this period, subjects will be requested to complete a diary outlining their cigarette and alcohol craving and consumption each day and outline any adverse effects. Upon completion of this 1-week period, subjects will attend the Centre for Addiction and Mental Health (CAMH) where their old pill bottles and daily diaries will be collected and they will be supplied with study medication (1mg varenicline taken twice daily or placebo) and daily diary for an additional week. At this visit, subjects will complete the symptom checklist. At the end of the second week of treatment, subjects will be requested to return to CAMH where craving for tobacco and alcohol and cue-reactivity will be assessed in a similar manner as to study day After study completion, all subjects will be given the option to continue with varenicline in a 12-week treatment plan through the Nicotine Dependence Clinic.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: Heavy Smokers/Heavy Drinkers

  • Treatment seeking smokers
  • Age 18 to 65 years
  • Smoke ≥ 10 cigarettes per day
  • Fagerstrom Test of Nicotine Dependence score > 3
  • Alcohol Use Disorders Identification Test (AUDIT) > 8
  • Drink > 25 drinks per week for males or > 20 drinks per week for females
  • Able to provide written informed consent

Inclusion Criteria (Heavy Smokers/Social Drinkers):

  • Treatment seeking smokers
  • Age 18 to 65 years
  • Smoke ≥ 10 cigarettes per day
  • Fagerstrom Test of Nicotine Dependence score > 3
  • Alcohol Use Disorders Identification Test(AUDIT) < 8
  • Drink < 14 drinks per week for males or < 9 drinks per week for females
  • Able to provide written informed consent

Exclusion Criteria (Heavy Smokers/Heavy Drinkers):

  • Any medical condition requiring immediate investigation or treatment
  • Beck Depression Inventory score >16
  • Insulin-dependent diabetes
  • Drink > 70 standard alcoholic drinks per week for males or drink > 52 standard alcoholic drinks per week for females
  • Pregnancy or lactation
  • Current DSM-IV Axis 1 psychiatric disorder
  • Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol.

Exclusion Criteria (Heavy Smokers/Social Drinkers):

  • Any medical condition requiring immediate investigation or treatment
  • Beck Depression Inventory score >16
  • Insulin-dependent diabetes
  • Drink > 14 standard alcoholic drinks per week for males or > 9 standard alcoholic drinks per week for females
  • Pregnancy or lactation
  • Current DSM-IV Axis 1 psychiatric disorder
  • Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Varenicline
This group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).
Drug: Varenicline
This group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).
Other Names:
  • Champix
  • Chantix
Placebo Comparator: Placebo
This group (N=40) will receive placebo in the same dosing regimen as for Varenicline. The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).
Drug: Placebo
This group (n=40) will receive matching placebo capsules in the identical dosing regimen described for the Varenicline arm. The group will consist of heavy smokers who are heavy drinkers (n=20) and heavy smokers who are social drinkers (n=20).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Questionnaire of Smoking Urges and the Alcohol Craving Questionnaire. (This questionnaire is used following visual cue presentation consisting of smoking, drinking and neutral pictures).
Time Frame: day 1, day 14
day 1, day 14

Collaborators and Investigators

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

Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Usoa E. Busto, Pharm.D., Centre for Addiction and Mental Health

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

Helpful Links

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

October 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114/2008

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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