Longitudinal Care: Smoking Reduction to Aid Cessation
2 other identifiers
interventional
443
1 country
1
Brief Summary
The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2005
Longer than P75 for not_applicable
1 active site
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
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 30, 2006
CompletedFirst Posted
Study publicly available on registry
March 31, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 14, 2011
February 1, 2011
4 years
March 30, 2006
February 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
6M prolonged abstinence
18M
Secondary Outcomes (4)
7d point prevalent abstinence
18M
30d point prevalent abstinence
18M
Smoking reduction
18M
Total duration of abstinence
18M
Study Arms (2)
Longitudinal Care
EXPERIMENTALOne year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.
Usual Care
ACTIVE COMPARATOREvidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks
Interventions
This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.
Eligibility Criteria
You may qualify if:
- Age 18-80
- Current and regular smoker 5 or more cigarettes per day
- Interested in making a quit attempt in the next 14 days
- Personal phone available
You may not qualify if:
- Pregnancy or plans to become pregnant in the next year
- Cannot speak English
- Not a union member or employee of specified worksite or immediate family member
- Member of household is currently enrolled in the study
- Not willing to comply with study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis VAMC
Minneapolis, Minnesota, 55417, United States
Related Publications (1)
Joseph AM, Fu SS, Lindgren B, Rothman AJ, Kodl M, Lando H, Doyle B, Hatsukami D. Chronic disease management for tobacco dependence: a randomized, controlled trial. Arch Intern Med. 2011 Nov 28;171(21):1894-900. doi: 10.1001/archinternmed.2011.500.
PMID: 22123795DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne M Joseph, MD, MPH
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 30, 2006
First Posted
March 31, 2006
Study Start
November 1, 2005
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
February 14, 2011
Record last verified: 2011-02