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

Tobacco Use Disorder Clinical Trial

— SHP  

Official title:

Self-determination and Maintaining Tobacco Abstinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178685
• Other study ID #: 10085
• Secondary ID: R01 CA106661R21C
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 15, 2013
• Start date: August 2004
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 837
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Smoking 5 or more cigarettes per day.

• 18 years of age or older.

• Speak and read English.

• Eligible regardless of desire to quit smoking

Exclusion Criteria:

• Pregnancy

• History of psychotic illness other than depression

• Life expectancy of less than 24 months

• Dementia, or incompetence for medical decision making

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

Intervention

Behavioral:
• Self-determination Intervention for Tobacco Dependence
autonomy supported behavioral intervention for tobacco dependent individuals

Locations

Country	Name	City	State
United States	Smokers' Health Project	Rochester	New York

Sponsors (6)

Lead Sponsor	Collaborator
University of Rochester	Greater Rochester Area Tobacco Cessation Center, Health Maintenance Consortium, National Cancer Institute (NCI), National Institutes of Health (NIH), New York State Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

Williams GC, McGregor H, Sharp D, Kouldes RW, Lévesque CS, Ryan RM, Deci EL. A self-determination multiple risk intervention trial to improve smokers' health. J Gen Intern Med. 2006 Dec;21(12):1288-94. — View Citation

Williams GC, McGregor HA, Sharp D, Levesque C, Kouides RW, Ryan RM, Deci EL. Testing a self-determination theory intervention for motivating tobacco cessation: supporting autonomy and competence in a clinical trial. Health Psychol. 2006 Jan;25(1):91-101. — View Citation

Williams GC, Minicucci DS, Kouides RW, Levesque CS, Chirkov VI, Ryan RM, Deci EL. Self-determination, smoking, diet and health. Health Educ Res. 2002 Oct;17(5):512-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.	The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.	12 months after subject completes intervention.	No
Secondary	7 Day Point Prevelence (7DPP)	Seven-day point prevalence abstinence (7DPP) was assessed by asking: "Have you smoked a cigarette, even a puff, in the last 7 days?"16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users.	12 months after the intervention	No

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