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Effect of Varenicline on Reactivity to Smoking and Drinking Cues

NCT00873535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-09-07

No results posted yet for this study

Summary

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.

Conditions

  • Tobacco Dependence
  • Alcohol Dependence

Interventions

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).

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).

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Usoa E. Busto, Pharm.D. · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00873535 on ClinicalTrials.gov