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An Alternative Dosing Schedule of Varenicline for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00835900
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: varenicline Drug: placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extended Varenicline for Smoking Cessation: A Pilot Study
Study Start Date : March 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: varenicline
drug plus counseling.
Drug: varenicline
variable dosing schedule
Other Name: Chantix
Active Comparator: placebo
placebo plus counseling
Drug: placebo
placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835900


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Pfizer
Investigators
Principal Investigator: Martin C Mahoney, MD, PhD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00835900     History of Changes
Obsolete Identifiers: NCT00957515
Other Study ID Numbers: I 136208
Pfizer IIR-GA30523
First Posted: February 4, 2009    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by Roswell Park Cancer Institute:
smoking cessation
varenicline
smoking cessation treatment

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs