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Completed

NCT Number: NCT00309296

Longitudinal Care: Smoking Reduction to Aid Cessation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smoking cessation

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.

Primary outcomes

  1. The primary endpoint will be 6M of abstinence measured 18M after enrollment.

    Time frame: 18M

    6M prolonged abstinence

Secondary outcomes

  1. 7d point prevalent abstinence

    Time frame: 18M

    Data collected at 21d, 3, 6, 12, 18M

  2. 30d point prevalent abstinence

    Time frame: 18M

    Data collected at 3, 6, 12, 18M

  3. Smoking reduction

    Time frame: 18M

    Data collected at 3, 6, 12, 18M

  4. Total duration of abstinence

    Time frame: 18M

    Time Line Follow Back

Sponsors and collaborators

Lead sponsor

National Institutes of Health (NIH)

Nih

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Mar 31, 2006
Registry last updated
Feb 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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