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Completed

NCT Number: NCT00835900

An Alternative Dosing Schedule of Varenicline for Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varenicline

Drug

variable dosing schedule

Other names: Chantix

Placebo

Drug

placebo

Primary outcomes

  1. Change in Smoking Behavior

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

    Change in cigarettes per day from Week 2 to Week 5

Secondary outcomes

  1. Rates of Smoking Cessation.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

Extended Varenicline for Smoking Cessation: A Pilot Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2015
First posted
Feb 4, 2009
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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