An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
2 other identifiers
interventional
525
1 country
2
Brief Summary
The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2009
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
July 8, 2015
CompletedJuly 8, 2015
June 1, 2015
4.8 years
January 11, 2010
May 27, 2015
June 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Point Prevalence Abstinence
self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide
52-week
Week 24 Point Prevalence Abstinence
self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide
24-week
Study Arms (3)
8 weeks transdermal nicotine
ACTIVE COMPARATOR8 weeks of transdermal nicotine
24 weeks transdermal nicotine
ACTIVE COMPARATOR24 weeks of transdermal nicotine
52 weeks transdermal nicotine
EXPERIMENTAL52 weeks of transdermal nicotine
Interventions
Transdermal nicotine, 21mg/day
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northwestern University
Chicago, Illinois, 60611, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (3)
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PMID: 39868569DERIVEDTheodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
PMID: 37335995DERIVEDSchnoll RA, Goelz PM, Veluz-Wilkins A, Blazekovic S, Powers L, Leone FT, Gariti P, Wileyto EP, Hitsman B. Long-term nicotine replacement therapy: a randomized clinical trial. JAMA Intern Med. 2015 Apr;175(4):504-11. doi: 10.1001/jamainternmed.2014.8313.
PMID: 25705872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Lack of placebo; low adherence to nicotine patches; nicotine patches are not the most effective treatment for nicotine dependence; participant attrition was high.
Results Point of Contact
- Title
- Dr. Robert Schnoll
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Hitsman, PhD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 13, 2010
Study Start
June 1, 2009
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
July 8, 2015
Results First Posted
July 8, 2015
Record last verified: 2015-06