Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction

Longitudinal Care: Smoking Reduction to Aid Cessation

Sponsors

Lead sponsor: National Institutes of Health (NIH)

Collaborator: National Institute on Drug Abuse (NIDA)

Source Minneapolis Veterans Affairs Medical Center
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.

Overall Status Completed
Start Date November 2005
Completion Date December 2009
Primary Completion Date November 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The primary endpoint will be 6M of abstinence measured 18M after enrollment. 18M
Secondary Outcome
Measure Time Frame
7d point prevalent abstinence 18M
30d point prevalent abstinence 18M
Smoking reduction 18M
Total duration of abstinence 18M
Enrollment 443
Condition
Intervention

Intervention type: Behavioral

Intervention name: smoking cessation

Description: 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:

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Anne M Joseph, MD, MPH Principal Investigator University of Minnesota
Location
facility Minneapolis VAMC
Location Countries

United States

Verification Date

February 2011

Responsible Party

Name title: Anne Joseph, MD, MPH

Organization: University of Minnesota

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Longitudinal Care

Arm group type: Experimental

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

Arm group label: Usual Care

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov