Longitudinal Care: Smoking Reduction to Aid Cessation

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Diseases
• Intervention / Treatment: Behavioral: smoking cessation

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.

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Longitudinal Care; One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.	Behavioral: 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.
Active Comparator: Usual Care; Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint will be 6M of abstinence measured 18M after enrollment.	6M prolonged abstinence	18M

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7d point prevalent abstinence	Data collected at 21d, 3, 6, 12, 18M	18M
30d point prevalent abstinence	Data collected at 3, 6, 12, 18M	18M
Smoking reduction	Data collected at 3, 6, 12, 18M	18M
Total duration of abstinence	Time Line Follow Back	18M

Collaborators and Investigators

• Sponsor: National Institutes of Health (NIH)
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Anne M Joseph, MD, MPH, University of Minnesota

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: March 30, 2006
• First Submitted That Met QC Criteria: March 30, 2006
• First Posted (Estimate): March 31, 2006

Study Record Updates

• Last Update Posted (Estimate): February 14, 2011
• Last Update Submitted That Met QC Criteria: February 11, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: smoking cessation; nicotine replacement therapy; smoking reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: TLC (Trichotillomania Learning Center); P50DA013333-07 (U.S. NIH Grant/Contract)