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

Primary Purpose

Alcohol Reactivity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
varenicline
placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Reactivity focused on measuring alcohol, reactivity, smoking cessation medications

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

varenicline

placebo

Arm Description

varenicline 1mg/day or 2mg/day

placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 22, 2009
Last Updated
January 22, 2018
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01000987
Brief Title
Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Official Title
Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Reactivity
Keywords
alcohol, reactivity, smoking cessation medications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varenicline
Arm Type
Experimental
Arm Description
varenicline 1mg/day or 2mg/day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Cognitive Function as Measured by Omissions on the CPT
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry A McKee, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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