Do Treatments for Smoking Cessation Affect Alcohol Drinking?



Status:Completed
Conditions:Smoking Cessation, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - Any
Updated:2/9/2018
Start Date:April 2007
End Date:November 2016

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The purpose of this study is to examine the effect of smoking cessation medications on
alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.

Following 7 days of medication pre-treatment to achieve steady state levels, participants
complete a laboratory session assessing alcohol self-administration behavior.

Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily
smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.


Inclusion Criteria:

- 21 years old or older

- Able to read and write in English

- Smokers, non-daily smokers, and non-smokers

- Heavy Drinkers and/or meet criteria for alcohol use disorders

Exclusion Criteria:

- Any significant current medical or psychiatric conditions that would contraindicate
the consumption of alcohol

- Significant hepatocellular injury

- Positive test result at intake appointments on urine drug screens conducted for
opiates, cocaine, or benzodiazepines

- Women who are pregnant or nursing

- Suicidal, homicidal, or evidence of severe mental illness

- Prescription of any psychotropic drug in the 30 days prior to study enrollment

- Blood donation within the past 8 weeks

- Individuals who are seeking treatment for drinking or smoking or who have attempted to
quit drinking or smoking within the past 3 months

- Specific exclusions for administration of bupropion not specified above including:
having taken monoamine inhibitors in the past six weeks; history of anorexia or
bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence
in the past year; history of seizure disorder of any etiology

- Known allergy to varenicline or taking H2blockers

- Participation within the past 8 weeks in other studies that involve additive blood
sampling and/or interventional measures that would be considered excessive in
combination with the current study

- Subjects likely to exhibit clinically significant alcohol withdrawal during the study
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