An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Extended Varenicline for Smoking Cessation: A Pilot Study
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 4, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedMay 30, 2017
April 1, 2017
1.3 years
February 3, 2009
March 13, 2017
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Smoking Behavior
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.
12 weeks after quit date.
Study Arms (2)
varenicline
EXPERIMENTALdrug plus counseling.
placebo
ACTIVE COMPARATORplacebo plus counseling
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- Pfizercollaborator
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Related Publications (1)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Martin Mahoney
- Organization
- Roswell Park Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Martin C Mahoney, MD, PhD
Roswell Park Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 4, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2015
Last Updated
May 30, 2017
Results First Posted
May 30, 2017
Record last verified: 2017-04