Longitudinal Care: Smoking Reduction to Aid Cessation

NCT ID: NCT00309296

Last Updated: 2011-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Chronic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Longitudinal Care

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

Group Type: EXPERIMENTAL

smoking cessation

Intervention Type: BEHAVIORAL

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.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

smoking cessation

Intervention Type: BEHAVIORAL

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.

Interventions

smoking cessation

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: lead

Responsible Party

University of Minnesota

Principal Investigators

Anne M Joseph, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Minneapolis VAMC

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22123795 (View on PubMed)

Other Identifiers

P50DA013333-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TLC

Identifier Type: -

Identifier Source: org_study_id