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

NCT01000987 | Completed Phase 2 Results DMC

• 1 other identifier: 0907005525
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Reactivity

Keywords

alcohol; reactivity; smoking cessation medications

Outcome Measures

Primary Outcomes (1)

• 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).

  Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.

Study Arms (2)

varenicline

EXPERIMENTAL

varenicline 1mg/day or 2mg/day

Drug: varenicline

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

varenicline DRUG

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.

Also known as: Chantix

varenicline

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Able to read and write in English
• Smokers and nonsmokers
• Meet criteria for alcohol use disorders
• Currently enrolled in NCT00580645

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

Varenicline

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Sherry McKee PhD
• Organization: Yale University

sherry.mckee@yale.edu

203-737-3529

Study Officials

• Sherry A McKee, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 19, 2018
• Results First Posted: February 19, 2018

Record last verified: 2018-01

Locations

US (1)