An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Extended Varenicline for Smoking Cessation: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: placebo; Drug: varenicline

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: varenicline; drug plus counseling.	Drug: varenicline; variable dosing schedule; Other Names: Chantix
Active Comparator: placebo; placebo plus counseling	Drug: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.	12 weeks after quit date.

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: Pfizer
• Investigators: Principal Investigator: Martin C Mahoney, MD, PhD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: smoking cessation; varenicline; smoking cessation treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: I 136208; Pfizer IIR-GA30523