Longitudinal Care: Smoking Reduction to Aid Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00309296
First received: March 30, 2006
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Chronic Diseases
Behavioral: smoking cessation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • The primary endpoint will be 6M of abstinence measured 18M after enrollment. [ Time Frame: 18M ] [ Designated as safety issue: No ]
    6M prolonged abstinence


Secondary Outcome Measures:
  • 7d point prevalent abstinence [ Time Frame: 18M ] [ Designated as safety issue: No ]
    Data collected at 21d, 3, 6, 12, 18M

  • 30d point prevalent abstinence [ Time Frame: 18M ] [ Designated as safety issue: No ]
    Data collected at 3, 6, 12, 18M

  • Smoking reduction [ Time Frame: 18M ] [ Designated as safety issue: No ]
    Data collected at 3, 6, 12, 18M

  • Total duration of abstinence [ Time Frame: 18M ] [ Designated as safety issue: No ]
    Time Line Follow Back


Enrollment: 443
Study Start Date: November 2005
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309296

Locations
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Investigators
Principal Investigator: Anne M Joseph, MD, MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by Minneapolis Veterans Affairs Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Joseph, MD, MPH, University of Minnesota
ClinicalTrials.gov Identifier: NCT00309296     History of Changes
Other Study ID Numbers: TLC, P50DA013333-07
Study First Received: March 30, 2006
Last Updated: February 11, 2011
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
smoking cessation
smoking reduction
nicotine replacement therapy

Additional relevant MeSH terms:
Chronic Disease
Smoking
Disease Attributes
Pathologic Processes
Habits

ClinicalTrials.gov processed this record on July 20, 2014