An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: placebo; Drug: varenicline

• Registration Number: NCT00835900
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.

Detailed Description

This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.

Study Timeline

• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Study Start: 2009-03
• Primary Completion: 2010-07
• Study Completion: 2015-07
• Results First Submitted: 2017-03-13
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-24
• Last Update Submitted: 2017-04-24
• Results First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• currently smoking at least 15 cigarettes daily
• in good health
• able to read and speak English fluently
• have a home telephone and plan to reside in Western New York for 6 months
• willing to make quit attempt
• signed informed consent
• who planned quit attempt.

Exclusion Criteria

• serious medical condition
• depression or mental health condition requiring treatment in the past year
• history of panic disorder, psychosis, bipolar disorder
• alcohol or drug abuse in the past year
• use of tobacco products other than cigarettes
• current use of other cessation pharmacotherapies
• pregnancy/planned pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo plus counseling
varenicline	varenicline	drug plus counseling.

Primary Outcome Measures

Name	Time	Method
Change in Smoking Behavior	Change in cigarettes per day from Week 2 to Week 5	Change in cigarettes per day from Week 2 to Week 5

Secondary Outcome Measures

Name	Time	Method
Rates of Smoking Cessation.	12 weeks after quit date.	To parallel most clinical trials of varenicline, we focused on CO-verified (\<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States