Prolonged Smoking Cessation Using Prescription Step Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Tennessee.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00170079
First received: September 12, 2005
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

Smoking is the number one preventable cause of morbidity and mortality in this nation. Unfortunately, more than 50% of those who quit following a smoking cessation intervention typically relapse within two weeks, with approximately 80% relapsing within six months. Therefore, tobacco use can be conceptualized as a chronic condition. As with many chronic medical problems, tobacco use interventions may benefit from a step care approach to treatment.

A total of 400 adult smokers will be enrolled in the study. Participants will be randomly assigned to one of two treatment conditions consisting of: 1) A State of the Art Smoking Cessation Intervention + Recycling or: 2) A State of the Art Smoking Cessation Intervention + Step Care. Long term smoking cessation will be assessed by self-report, exhaled carbon monoxide levels, and salivary cotinine. The primary endpoint of the study will be smoking abstinence rates at two-year follow-up. It is predicted that long-term cessation rates will be significantly higher in the step care condition than for those assigned to the recycling group.


Condition Intervention
Tobacco Dependence
Behavioral: Smoking Cessation Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prolonged Smoking Cessation Using Prescription Step Care

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Long term smoking cessation using both prolonged and point prevalence abstinence criteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2005
Estimated Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Smoking Cessation Intervention

    A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of "step care." The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:

    Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;

    Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and

    Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition.

Detailed Description:

A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. Despite a high degree of interest in applying the step care model to smoking cessation (Abrams et al., 1996; Hughes, 1994), little empirical work has been conducted utilizing this treatment approach. The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:

Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;

Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and

Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Cigarette smokers who are 18 years of age or older, who self-report smoking at least 10 cigarettes each day, and who are willing to accept random assignment are eligible to participate. Potential participants must agree to commit to the study for at least 24 months, be screened and agree to potentially participate in more intensive interventions to help them stop smoking, and agree to not seek other treatment for smoking cessation during the treatment phase of the study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170079

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Robert C. Klesges, Ph.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Robert C. Klesges, Ph.D.., University of Tennessee
ClinicalTrials.gov Identifier: NCT00170079     History of Changes
Other Study ID Numbers: 1730-04, R01CA106667-01
Study First Received: September 12, 2005
Last Updated: June 29, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014