NCT01286584

Brief Summary

The aim of this study is to assess the efficacy of varenicline compared to placebo in tobacco dependent individuals who are undergoing concurrent treatment for alcohol dependence. As they will be inpatients and under 24 hour medical care for the first 21 days of treatment, or receiving outpatient treatment through the Alcohol Research and Treatment Clinic, this will allow for a comprehensive assessment of the safety of varenicline in this population with minimal risk of adverse consequences. The patients will continue their cessation treatment for an additional 10 weeks as outpatients through the Nicotine Dependence Clinic at CAMH. They will also be contacted at 6 months for follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2011

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

January 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

January 28, 2011

Last Update Submit

February 3, 2015

Conditions

Smoking CessationAlcohol Abuse

Keywords

vareniclinealcoholplacebosmoking cessation

Outcome Measures

Primary Outcomes (1)

  • quit smoking rating

    7-day point prevalence

    end of 12-week treatment

Secondary Outcomes (1)

  • 30 day continuous smoking abstinence

    6-month follow-up

Study Arms (2)

varenicline group

ACTIVE COMPARATOR
Drug: varenicline

placebo group

PLACEBO COMPARATOR
Drug: placebo

Interventions

vareniclineDRUG

one 0.5mg varenicline capsule on first 3 days one 0.5mg varenicline capsule, twice daily for 4 days one 1.0mg varenicline capsule, twice daily until end of treatment (12weeks of medication

Also known as: Champix, Chantix
varenicline group
placeboDRUG

lactose filler in capsules identical to the varenicline capsules one 0.5mg capsule for 3 days one 0.5mg capsule twice daily for 4 days one 1.0mg capsule twice daily until end of treatment (12weeks of medication)

placebo group

Eligibility Criteria

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

You may qualify if:

  • current daily smokers enrolled in residential treatment or outpatient in Alcohol Treatment and Research Clinic for Alcohol Use Disorder at CAMH
  • smoke minimum of 10 cigarettes per day
  • Fagerstrom Test of Nicotine Dependence score \> 3
  • able to provide written informed consent
  • able and willing to attend weekly appointments at the NDC following discharge

You may not qualify if:

  • any serious medical condition requiring immediate investigation or treatment
  • pregnancy or lactation
  • current DSM-IV Axis I psychiatric disorder
  • any know contraindication to using varenicline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Toronto, Ontario, M5T 1P7, Canada

Location

Related Links

MeSH Terms

Conditions

Smoking CessationAlcoholism

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Laurie Zawertailo, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Independent Scientist

Study Record Dates

First Submitted

January 28, 2011

First Posted

January 31, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

CA(1)