Clinical trial NCT00309296: Longitudinal Care: Smoking Reduction to Aid Cessation
Official title: Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Keywords: smoking cessation
smoking reduction
nicotine replacement therapy
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-03-31
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.

Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.

Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The primary endpoint will be 6M of abstinence measured 18M after enrollment.
timeFrame: 18M
Secondary outcomes:
measure: 7d point prevalent abstinence
timeFrame: 18M
measure: 30d point prevalent abstinence
timeFrame: 18M
measure: Smoking reduction
timeFrame: 18M
measure: Total duration of abstinence
timeFrame: 18M
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Anne M Joseph, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.