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An Alternative Dosing Schedule of Varenicline for Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00835900
First received: February 3, 2009
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Smoking Cessation
 Drug: varenicline
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extended Varenicline for Smoking Cessation: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Changes in smoking behavior, as well as smoking satisfaction, craving, and withdrawal. [ Time Frame: daily ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rates of smoking cessation. [ Time Frame: 12 weeks after quit date. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: varenicline
drug plus counseling.
 Drug: varenicline
variable dosing schedule
Other Name: Chantix
Active Comparator: placebo
placebo plus counseling
 Drug: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 3, 2009
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013