An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Extended Varenicline for Smoking Cessation: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835900
• Other study ID #: I 136208
• Secondary ID: Pfizer IIR-GA305
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2009
• Last updated: August 11, 2015
• Start date: March 2009
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00957515

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• varenicline
variable dosing schedule
• placebo
placebo

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in smoking behavior, as well as smoking satisfaction, craving, and withdrawal.		daily	Yes
Secondary	Rates of smoking cessation.		12 weeks after quit date.	Yes