Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking? - NCT00580645-06519 (Clinical Trial 196850)
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| City: |
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New Haven |
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State:
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CT |
| Zip Code: |
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06519 |
| Conditions: |
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Alcohol Drinking |
| Purpose: |
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The purpose of this study is to examine the effect of smoking cessation medications on
alcohol drinking.
Following 7 days of medication pre-treatment to achieve steady state levels, participants
complete a laboratory session assessing alcohol self-administration behavior and a cue
reactivity session assessing their reactivity to alcohol-related cues. Subjects are
maintained on study medication for 4 weeks after the laboratory session.
The study is subdivided into three studies based on subject population.
Study 1A enrolls heavy drinking smokers (tested under nicotine deprivation). Study 1B
enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers,
and nonsmokers. Study 1C enrolls smokers (not tested under nicotine deprivation) and
nonsmokers who meet criteria for alcohol use disorders.
In Study 1A, volunteers are administered either varenicline (Chantix), bupropion (Zyban), or
placebo. In Studies 1B and 1C, volunteers are administered either varenicline (Chantix) or
placebo.
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| Study summary: |
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| Criteria: |
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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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| Study is available at: |
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Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory
New Haven, CT 06519
United States
Primary Contact:
Erika Balchunas
Phone: 203-737-2783 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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