Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Drinking |
Drug: varenicline Drug: bupropion Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking? |
- number of drinks consumed [ Time Frame: throughout the laboratory session ] [ Designated as safety issue: No ]
- tobacco and alcohol craving [ Time Frame: during laboratory session ] [ Designated as safety issue: No ]
- tobacco and alcohol craving [ Time Frame: during the cue reactivity session ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 308 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: varenicline
Studies 1A and 1B: varenicline 2mg/day Study 1C: varenicline 1mg/day or 2mg/day |
Drug: varenicline
Studies 1A and 1B: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered twice daily during laboratory session (day 8) and for 4 weeks after laboratory session. Study 1C: 2mg/day (see above) or 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. Other Name: Chantix
|
|
Experimental: Bupropion
Study 1A only: Bupropion 300mg/day
|
Drug: bupropion
Study 1A only: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8) and for 4 weeks after laboratory session.
Other Name: Zyban
|
|
Placebo Comparator: Placebo
Placebo Controlled
|
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Sabrina Coppola | 203-737-2783 |
| United States, Connecticut | |
| Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Principal Investigator: Sherry A McKee, PhD | |
| Principal Investigator: | Sherry A McKee, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Sherry McKee, Associate Professor of Psychiatry, Yale University |
| ClinicalTrials.gov Identifier: | NCT00580645 History of Changes |
| Other Study ID Numbers: | HIC0702002391, R01AA015596-01 |
| Study First Received: | December 25, 2007 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Yale University:
|
alcohol smoking cessation varenicline bupropion smoking cessation medications |
Additional relevant MeSH terms:
|
Alcohol Drinking Smoking Drinking Behavior Habits Ethanol Bupropion Varenicline Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs |
Central Nervous System Agents Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
ClinicalTrials.gov processed this record on June 17, 2013