Phase 2 Completed N=44 Randomized Triple-blind Treatment

Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

Alcohol Reactivity

Source: ClinicalTrials.gov NCT01000987 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcomePrimary: Cognitive Function as Measured by Omissions on the CPT — 1.78; 1.28; 4.76; 0.98 Number of Omissions

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.