Prolonged Smoking Cessation Using Prescription Step Care

NCT00170079 | Completed DMC

• 2 other identifiers: 1730-04R01CA106667-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Long term smoking cessation using both prolonged and point prevalence abstinence criteria

  24 months

Study Arms (1)

Step care vs. regular care

EXPERIMENTAL

Participants were randomized either to (1) Step care intervention, where smokers who failed to quit or who relapsed received increasingly intensive smoking cessation interventions; vs. (2) Regular care, where smokers who failed to quit or who relapsed received repeated intervention.

Behavioral: Smoking Cessation Intervention

Interventions

Smoking Cessation Intervention BEHAVIORAL

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.

Step care vs. regular care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Tennessee: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

Related Publications (1)

• Ebbert JO, Little MA, Klesges RC, Bursac Z, Johnson KC, Thomas F, Vander Weg MW. Step Care treatment for smoking cessation. Health Educ Res. 2017 Feb 1;32(1):1-11. doi: 10.1093/her/cyw051.

  PMID: 28158558 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Robert C. Klesges, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Preventive Medicine

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (2)