NCT00832806

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

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

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

Enrollment Period

3.8 years

First QC Date

January 28, 2009

Last Update Submit

November 28, 2011

Conditions

Additional, Effective Methods to Stop Smoking

Keywords

smokingChampixIntegrated Voice Response technology

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Self-reported date of smoking and number of cigarettes smoked from weeks 13 to 52.

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Extended IVR (integrated voice response technology) vs. no extended IVR

Behavioral: Extended IVR (integrated voice response technology)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

Interventions

Extended IVR (integrated voice response technology)BEHAVIORAL

See detailed description

1
Varenicline (Champix)DRUG

See detailed description

12
IVR treatmentBEHAVIORAL

See detailed description

12

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Heart Program, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (2)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

  • McNaughton B, Frohlich J, Graham A, Young QR. Extended interactive voice response telephony (IVR) for relapse prevention after smoking cessation using varenicline and IVR: a pilot study. BMC Public Health. 2013 Sep 10;13:824. doi: 10.1186/1471-2458-13-824.

    PMID: 24020450DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jiri Frohlich, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 30, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

CA(1)