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

March 30, 2006
February 11, 2011
November 2005
November 2009   (final data collection date for primary outcome measure)
The primary endpoint will be 6M of abstinence measured 18M after enrollment. [ Time Frame: 18M ] [ Designated as safety issue: No ]
6M prolonged abstinence
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
Complete list of historical versions of study NCT00309296 on ClinicalTrials.gov Archive Site
  • 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
Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction.
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Diseases
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.
  • Experimental: Longitudinal Care
    One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.
    Intervention: Behavioral: smoking cessation
  • Active Comparator: Usual Care
    Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks
    Intervention: Behavioral: smoking cessation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
443
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00309296
TLC, P50DA013333-07
No
Anne Joseph, MD, MPH, University of Minnesota
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Principal Investigator: Anne M Joseph, MD, MPH University of Minnesota - Clinical and Translational Science Institute
Minneapolis Veterans Affairs Medical Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP