Alcohol Drinking
Conditions
Keywords
alcohol, smoking cessation, varenicline, bupropion, smoking cessation medications
Brief summary
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.
Interventions
DRUGvarenicline
2mg/day or 1mg/day with 1-week medication lead-in period.
DRUGplacebo
placebo
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinks Consumed | 2 hour ad-lib drinking period, during the laboratory session (Day 8) | number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Craving | during laboratory session (Day 8) at baseline | alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo controlled
placebo: placebo | 20 |
| 1 mg/Day Varenicline 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. | 20 |
| 2 mg/Day Varenicline 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo | 1 mg/Day Varenicline | 2 mg/Day Varenicline | Total |
|---|---|---|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 9.52 | 33.35 years STANDARD_DEVIATION 8.51 | 34.15 years STANDARD_DEVIATION 11.6 | 33.90 years STANDARD_DEVIATION 9.8 |
| Race/Ethnicity, Customized African American | 8 Participants | 7 Participants | 2 Participants | 17 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 10 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 15 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 7 / 20 | 4 / 20 | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Number of Drinks Consumed
number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session
Time frame: 2 hour ad-lib drinking period, during the laboratory session (Day 8)
Population: number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Drinks Consumed | hour 1 | 2.1 number of drinks | Standard Error 0.37 |
| Placebo | Number of Drinks Consumed | hour 2 | 1.7 number of drinks | Standard Error 0.37 |
| 1 mg/Day Varenicline | Number of Drinks Consumed | hour 1 | 2.05 number of drinks | Standard Error 0.32 |
| 1 mg/Day Varenicline | Number of Drinks Consumed | hour 2 | 2.05 number of drinks | Standard Error 0.37 |
| 2 mg/Day Varenicline | Number of Drinks Consumed | hour 1 | 1.5 number of drinks | Standard Error 0.33 |
| 2 mg/Day Varenicline | Number of Drinks Consumed | hour 2 | 1.5 number of drinks | Standard Error 0.37 |
Secondary
Alcohol Craving
alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)
Time frame: during laboratory session (Day 8) at baseline
Population: n=19 in the 2mg/day varenicline group because 1 subject failed to respond on measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Alcohol Craving | 37.24 units on a visual analog scale | Standard Error 5.32 |
| 1 mg/Day Varenicline | Alcohol Craving | 34.11 units on a visual analog scale | Standard Error 5.32 |
| 2 mg/Day Varenicline | Alcohol Craving | 24.04 units on a visual analog scale | Standard Error 5.33 |