NCT00580645

Brief Summary

The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated. Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior. Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 7, 2018

Completed
Last Updated

February 7, 2018

Status Verified

January 1, 2018

Enrollment Period

9.6 years

First QC Date

December 25, 2007

Results QC Date

November 20, 2017

Last Update Submit

January 8, 2018

Conditions

Alcohol Drinking

Keywords

alcoholsmoking cessationvareniclinebupropionsmoking cessation medications

Outcome Measures

Primary Outcomes (1)

  • Number of Drinks Consumed

    number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session

    2 hour ad-lib drinking period, during the laboratory session (Day 8)

Secondary Outcomes (1)

  • Alcohol Craving

    during laboratory session (Day 8) at baseline

Study Arms (2)

varenicline

EXPERIMENTAL

varenicline 1mg/day or 2mg/day

Drug: varenicline

Placebo

PLACEBO COMPARATOR

Placebo Controlled

Drug: placebo

Interventions

vareniclineDRUG

2mg/day or 1mg/day with 1-week medication lead-in period.

Also known as: Chantix
varenicline
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Able to read and write in English
  • Smokers, non-daily smokers, and non-smokers
  • Heavy Drinkers and/or meet criteria for alcohol use disorders

You may not qualify if:

  • Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
  • Significant hepatocellular injury
  • Positive test result 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 study
  • Subjects likely to exhibit clinically significant alcohol withdrawal during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Roberts W, McKee SA. Effects of varenicline on cognitive performance in heavy drinkers: Dose-response effects and associations with drinking outcomes. Exp Clin Psychopharmacol. 2018 Feb;26(1):49-57. doi: 10.1037/pha0000161.

    PMID: 29389170DERIVED

MeSH Terms

Conditions

Alcohol DrinkingSmoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
Sherry McKee PhD
Organization
Yale School of Medicine
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

December 25, 2007

First Posted

December 27, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 7, 2018

Results First Posted

February 7, 2018

Record last verified: 2018-01

Locations

US(1)