An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Roswell Park Cancer Institute60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Smoking Cessation

Interventions

vareniclineDRUG

variable dosing schedule

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Outcomes

Primary Outcomes

Change in Smoking Behavior

Change in cigarettes per day from Week 2 to Week 5

Time frame: Change in cigarettes per day from Week 2 to Week 5

Secondary Outcomes

Rates of Smoking Cessation.

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.

Time frame: 12 weeks after quit date.

Data from ClinicalTrials.gov

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