Longitudinal Care: Smoking Reduction to Aid Cessation

National Institutes of Health (NIH)

Status: Completed

Conditions: Chronic Diseases

Treatments: Behavioral: smoking cessation

Study type: Interventional

Funder types: NIH

Identifiers

NCT00309296

TLC

P50DA013333-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 443 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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443 participants in 2 patient groups

Longitudinal Care

Experimental group

Description:

One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.

Treatment:

Behavioral: smoking cessation

Usual Care

Active Comparator group

Description:

Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks

Treatment:

Behavioral: smoking cessation