Phase 2
N=44
Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Alcohol Reactivity
Bottom Line
View on ClinicalTrials.gov: NCT01000987 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Cognitive Function as Measured by Omissions on the CPT — 1.78; 1.28; 4.76; 0.98 Number of Omissions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- varenicline (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Function as Measured by Omissions on the CPT |
1.78; 1.28; 4.76; 0.98; 0.62; 2.37 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01000987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.