Smoke-Free Living Study - Full Text View

Sponsors and Collaborators:	University of British Columbia Pfizer Pharmaceutical
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00832806

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline

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 ]

Estimated Enrollment:	81
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Extended IVR (integrated voice response technology) vs. no extended IVR	Behavioral: Extended IVR (integrated voice response technology) See detailed description Drug: Varenicline (Champix) Behavioral: IVR treatment
2: Active Comparator Extended IVR (integrated voice response technology) vs. no extended IVR	Drug: Varenicline (Champix) Behavioral: IVR treatment

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

Contacts

Contact: Bonnie McNaughton, RN

604-806-9844

bmcnaughton@providencehealth.bc.ca

Locations

Canada, British Columbia
Healthy Heart Program, St. Paul's Hospital	Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Bonnie McNaughton, RN 604-806-9844 bmcnaughton@providencehealth.bc.ca

Sponsors and Collaborators

University of British Columbia

Pfizer Pharmaceutical

Investigators

Principal Investigator:

Jiri Frohlich, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. Jiri Frohlich )
Study ID Numbers:	H07 - 01287
Study First Received:	January 28, 2009
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00832806 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

smoking
Champix
Integrated Voice Response technology

Study placed in the following topic categories:

Smoking
Varenicline

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on August 28, 2009