NCT00873535

Brief Summary

Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline. Hypotheses

  1. 1.Two weeks of varenicline treatment will significantly decrease cue-induced tobacco craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2 receptors and its downstream effect on dopamine release).
  2. 2.Varenicline will decrease cue-induced alcohol craving compared to placebo.
  3. 3.The impact of Varenicline on cue-induced alcohol craving will be greater in heavy drinkers compared to social drinkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

March 31, 2009

Last Update Submit

September 3, 2015

Conditions

Tobacco DependenceAlcohol Dependence

Keywords

NicotineNicotine dependenceSmoking cessationAlcoholAlcohol dependenceAlcohol cessationTreatmentSmokingCigaretteHeavy drinkersSocial drinkersCo-morbidity of alcohol and nicotine dependenceNicotine receptorNicotinic receptorNicotinic acetycholine receptorAlpha-4-beta-2 nicotinic acetycholine receptorCholinergic receptorDopamineCravingDiaryCue inducedPharmacotherapyVareniclineChantixChampix

Outcome Measures

Primary Outcomes (1)

  • The Questionnaire of Smoking Urges and the Alcohol Craving Questionnaire. (This questionnaire is used following visual cue presentation consisting of smoking, drinking and neutral pictures).

    day 1, day 14

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

This group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

This group (N=40) will receive placebo in the same dosing regimen as for Varenicline. The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).

Drug: Placebo

Interventions

VareniclineDRUG

This group (N=40) will receive Varenicline (0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily for days 8-14). The group will consist of heavy smokers and heavy drinkers (N=20) and heavy smokers and social drinkers (N=20).

Also known as: Chantix, Champix
Varenicline
PlaceboDRUG

This group (n=40) will receive matching placebo capsules in the identical dosing regimen described for the Varenicline arm. The group will consist of heavy smokers who are heavy drinkers (n=20) and heavy smokers who are social drinkers (n=20).

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment seeking smokers
  • Age 18 to 65 years
  • Smoke ≥ 10 cigarettes per day
  • Fagerstrom Test of Nicotine Dependence score \> 3
  • Alcohol Use Disorders Identification Test (AUDIT) \> 8
  • Drink \> 25 drinks per week for males or \> 20 drinks per week for females
  • Able to provide written informed consent
  • Treatment seeking smokers
  • Age 18 to 65 years
  • Smoke ≥ 10 cigarettes per day
  • Fagerstrom Test of Nicotine Dependence score \> 3
  • Alcohol Use Disorders Identification Test(AUDIT) \< 8
  • Drink \< 14 drinks per week for males or \< 9 drinks per week for females
  • Able to provide written informed consent

You may not qualify if:

  • Any medical condition requiring immediate investigation or treatment
  • Beck Depression Inventory score \>16
  • Insulin-dependent diabetes
  • Drink \> 70 standard alcoholic drinks per week for males or drink \> 52 standard alcoholic drinks per week for females
  • Pregnancy or lactation
  • Current DSM-IV Axis 1 psychiatric disorder
  • Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol.
  • Any medical condition requiring immediate investigation or treatment
  • Beck Depression Inventory score \>16
  • Insulin-dependent diabetes
  • Drink \> 14 standard alcoholic drinks per week for males or \> 9 standard alcoholic drinks per week for females
  • Pregnancy or lactation
  • Current DSM-IV Axis 1 psychiatric disorder
  • Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (1)

  • Acheson A, Mahler SV, Chi H, de Wit H. Differential effects of nicotine on alcohol consumption in men and women. Psychopharmacology (Berl). 2006 May;186(1):54-63. doi: 10.1007/s00213-006-0338-y. Epub 2006 Mar 25.

    PMID: 16565827BACKGROUND

Related Links

MeSH Terms

Conditions

Tobacco Use DisorderAlcoholismSmoking CessationSmoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Usoa E. Busto, Pharm.D.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Scientist

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

CA(1)