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Extended Varenicline for Smoking Cessation: A Pilot Study

Phase 2
18 Years
65 Years
Open (Enrolling)
Smoking Cessation

Thank you

Trial Information

Extended Varenicline for Smoking Cessation: A Pilot Study

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Changes in smoking behavior, as well as smoking satisfaction, craving, and withdrawal.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Martin C Mahoney, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:

I 136208



Start Date:

March 2009

Completion Date:

June 2013

Related Keywords:

  • Smoking Cessation
  • smoking cessation
  • varenicline
  • smoking cessation treatment
  • Smoking



Roswell Park Cancer InstituteBuffalo, New York  14263