Alcohol Reactivity
Conditions
Keywords
alcohol, reactivity, smoking cessation medications
Brief summary
The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.
Interventions
DRUGvarenicline
1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.
DRUGplacebo
placebo
Sponsors
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 and nonsmokers * Meet criteria for alcohol use disorders * Currently enrolled in NCT00580645
Exclusion criteria
* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol * Significant hepatocellular injury * Positive test results 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 * 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 protocol * Subjects likely to exhibit clinically significant alcohol withdrawal during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function as Measured by Omissions on the CPT | Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption. | Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with stop and go targets that appear on a computer screen. They are told to press the space bar (respond) to go targets and to avoid pressing the space bar when stop targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324). |
Countries
United States
Participant flow
Recruitment details
Of the n=60 subjects who completed the parent study (NCT00580645), n=44 elected to also complete the current protocol.
Participants by arm
| Arm | Count |
|---|---|
| 1 mg/Day Varenicline varenicline 1mg/day
varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. | 12 |
| 2 mg/Day Varenicline varenicline 2mg/day
varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. | 15 |
| Placebo placebo
placebo: placebo | 17 |
| Total | 44 |
Baseline characteristics
| Characteristic | 1 mg/Day Varenicline | 2 mg/Day Varenicline | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 7.29 | 34.4 years STANDARD_DEVIATION 12.6 | 35.3 years STANDARD_DEVIATION 9.47 | 34.6 years STANDARD_DEVIATION 9.96 |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 11 Participants | 29 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 | 4 / 20 | 5 / 20 | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Cognitive Function as Measured by Omissions on the CPT
Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with stop and go targets that appear on a computer screen. They are told to press the space bar (respond) to go targets and to avoid pressing the space bar when stop targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324).
Time frame: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg/Day Varenicline | Cognitive Function as Measured by Omissions on the CPT | Alcohol | 1.78 Number of Omissions | Standard Error 1.24 |
| 1 mg/Day Varenicline | Cognitive Function as Measured by Omissions on the CPT | Control Beverage | 0.98 Number of Omissions | Standard Error 1.24 |
| 2 mg/Day Varenicline | Cognitive Function as Measured by Omissions on the CPT | Alcohol | 1.28 Number of Omissions | Standard Error 1.11 |
| 2 mg/Day Varenicline | Cognitive Function as Measured by Omissions on the CPT | Control Beverage | 0.62 Number of Omissions | Standard Error 1.11 |
| Placebo | Cognitive Function as Measured by Omissions on the CPT | Alcohol | 4.76 Number of Omissions | Standard Error 1.05 |
| Placebo | Cognitive Function as Measured by Omissions on the CPT | Control Beverage | 2.37 Number of Omissions | Standard Error 1.05 |