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Smoke-Free Living Study

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00832806
First received: January 28, 2009
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Condition Intervention Phase
Additional, Effective Methods to Stop Smoking
 Behavioral: Extended IVR (integrated voice response technology)
Drug: Varenicline (Champix)
Behavioral: IVR treatment
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported date of smoking and number of cigarettes smoked from weeks 13 to 52. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Extended IVR (integrated voice response technology) vs. no extended IVR
 Behavioral: Extended IVR (integrated voice response technology)
See detailed description
Drug: Varenicline (Champix)
See detailed description
Behavioral: IVR treatment
See detailed description
Active Comparator: 2
Extended IVR (integrated voice response technology) vs. no extended IVR
 Drug: Varenicline (Champix)
See detailed description
Behavioral: IVR treatment
See detailed description

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoking 35 or more cigarettes per week or 5 or more cigarettes per day,
  • Smoking for at least 2 years, with no period of abstinence longer than 3 months.

Exclusion Criteria:

  • Using any smoking cessation drugs or nicotine replacement drugs in the last 3 months,
  • Use of medication to treat depression or any psychiatric illness,
  • Impaired renal function,
  • Unstable medical condition,
  • Pregnancy or breast feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832806

Locations
Canada, British Columbia
Healthy Heart Program, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Pfizer
Investigators
Principal Investigator: Jiri Frohlich, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00832806     History of Changes
Other Study ID Numbers: H07 - 01287
Study First Received: January 28, 2009
Last Updated: November 28, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
smoking
Champix
Integrated Voice Response technology

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013