Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence — SHP  

Tobacco Use Disorder Clinical Trial

Official title: Self-determination and Maintaining Tobacco Abstinence

Status Completed

Clinical Trial Summary

These two studies will examine the role of autonomous motivation in maintained adherence. The first study will determine whether smokers are still abstinent from tobacco 32 months after starting in a previous project (Smoker's Health Study). The purpose of the second study is to determine which of three treatments for tobacco dependence provides the greatest amount of protection from relapsing to smoking after quitting. Specifically, the investigators will determine if extending the length of treatment time focusing on relapse prevention and arranging for support from important others prevents relapse compared to community care. Also, the investigators will determine if providing extended treatment time and support from important others plus providing medications to those that don't want to quit prevents long term relapse compared to just extending the length of treatment time and support from others. Additionally, a sub set of the population will be randomized to using hand held palm devices to recover real-time data assessment during the last 10 months of the project.

Clinical Trial Description

These two studies will extend our examination of self-determination theory (SDT) based counseling interventions to the issue of maintained abstinence from tobacco use. Two projects are proposed, both of which build on the results of our current trial. The first is a 32-month follow-up of the smoking status of patients in the preceding trial called the Smoker's Health Study (self-determination, smoking, diet, and health). That SDT intervention (4 counselor visits over 6 months) increased cessation at 6 months relative to community care, and was also effective in increasing 12 month prolonged abstinence, and the results have been reported in two manuscripts (Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, In press; Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, 2005). The part of this first project that will be conducted as part of this grant will be to complete 32 month follow-up of smokers in the Smoker's Health Study. The second project is a 3-cell clinical trial called the Smoker's Health Project that will examine two extensions of the current intervention, both of which place greater emphasis on use of, and adherence to, cessation medications. The two arms will be compared to community care. Both arms involve two visits with a physician to discuss medications and side effects. In both interventions, counselors will address medication adherence. The two arms differ in that patients not ready to quit in one arm will receive a smoking reduction approach (with medications) in which they first try to reduce their smoking to half and then attempt cessation. In addition, to place greater emphasis on medications and to examine medication adherence as a mediator of maintained cessation.

There will be two major changes in the intervention intended to facilitate long-term maintenance. First, the intervention will extend over 12 months (whereas the current one lasts only 6 months) with meetings during the additional 6 months focusing on maintenance and relapse prevention. Second, at least one family member or best friend of each patient will be encouraged to meet with a counselor to learn how to be more autonomy supportive with the patient around issues related to tobacco. Cessation and maintained abstinence will be examined with logistic regression. The SDT process model of maintained cessation will be tested using structural equation modeling, and cost-effectiveness analyses will be done for the interventions. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

• NCT number: NCT00178685
• Study type: Interventional
• Source: University of Rochester
• Status: Completed
• Phase: Phase 4
• Start date: August 2004
• Completion date: August 2008