Clinical trial NCT00178685: Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence
Official title: Self-determination and Maintaining Tobacco Abstinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use Disorder
Keywords: Self-determination
motivation
adherence
competence
autonomy
tobacco dependence
Tobacco use and dependence
Behavior change
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: New York State Department of Health
name: Greater Rochester Area Tobacco Cessation Center
name: Health Maintenance Consortium
name: National Institutes of Health (NIH)
First posted: 2005-09-15
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.
timeFrame: 12 months after subject completes intervention.
Secondary outcomes:
measure: 7 Day Point Prevelence (7DPP)
timeFrame: 12 months after the intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Smokers' Health Project
state: New York
Study officials:
affiliation: University of Rochester
name: Geoffrey C Williams, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1037/0278-6133.25.1.91.
citation: Williams GC, McGregor H, Sharp D, Kouldes RW, Levesque 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. doi: 10.1111/j.1525-1497.2006.00621.x.
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. doi: 10.1093/her/17.5.512.
citation: Williams GC, Niemiec CP, Patrick H, Ryan RM, Deci EL. Outcomes of the Smoker's Health Project: a pragmatic comparative effectiveness trial of tobacco-dependence interventions based on self-determination theory. Health Educ Res. 2016 Dec;31(6):749-759. doi: 10.1093/her/cyw046. Epub 2016 Oct 22.
citation: Ternullo SR, Abdolahi A, Williams GC. Study of monotherapy versus combination therapy for tobacco dependence among heavily addicted smokers. J Am Pharm Assoc (2003). 2017 Jan-Feb;57(1):77-81.e1. doi: 10.1016/j.japh.2016.08.011. Epub 2016 Nov 11.
citation: Pesis-Katz I, Williams GC, Niemiec CP, Fiscella K. Cost-effectiveness of intensive tobacco dependence intervention based on self-determination theory. Am J Manag Care. 2011 Oct 1;17(10):e393-8.
citation: Williams GC, Patrick H, Niemiec CP, Ryan RM, Deci EL, Lavigne HM. The smoker's health project: a self-determination theory intervention to facilitate maintenance of tobacco abstinence. Contemp Clin Trials. 2011 Jul;32(4):535-43. doi: 10.1016/j.cct.2011.03.002. Epub 2011 Mar 5.
citation: Williams GC, Niemiec CP, Patrick H, Ryan RM, Deci EL. The importance of supporting autonomy and perceived competence in facilitating long-term tobacco abstinence. Ann Behav Med. 2009 Jun;37(3):315-24. doi: 10.1007/s12160-009-9090-y. Epub 2009 Apr 17.
citation: Niemiec CP, Ryan RM, Deci EL, Williams GC. Aspiring to physical health: the role of aspirations for physical health in facilitating long-term tobacco abstinence. Patient Educ Couns. 2009 Feb;74(2):250-7. doi: 10.1016/j.pec.2008.08.015. Epub 2008 Oct 5.