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

NCT00178685 | Completed Phase 4 Results

• 3 other identifiers: 10085R01 CA106661R21CA119112-01A2
• Study Type: interventional
• Target: 837
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Self-determination; motivation; adherence; competence; autonomy; tobacco dependence; Tobacco use and dependence; Behavior change

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 7 Day Point Prevelence (7DPP)

  12 months after the intervention

Interventions

Self-determination Intervention for Tobacco Dependence BEHAVIORAL

autonomy supported behavioral intervention for tobacco dependent individuals

Also known as: Smokers' Health Project

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking 5 or more cigarettes per day.
• years of age or older.
• Speak and read English.
• Eligible regardless of desire to quit smoking

You may not qualify if:

• Pregnancy
• History of psychotic illness other than depression
• Life expectancy of less than 24 months
• Dementia, or incompetence for medical decision making

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator
• New York State Department of Health: collaborator
• Greater Rochester Area Tobacco Cessation Center: collaborator
• Health Maintenance Consortium: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Smokers' Health Project

Rochester, New York, 14607, United States

Location

Related Publications (10)

• 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.

  PMID: 16448302 BACKGROUND

• 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.

  PMID: 16995893 BACKGROUND

• 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.

  PMID: 12408196 BACKGROUND

• Niemiec CP, Ivarsson A, Weman K, Smit E, Williams GC. Self-determination theory and the smoking cessation process: Daily electronic self-reports can identify the initiation of quit attempts. Patient Educ Couns. 2023 Oct;115:107886. doi: 10.1016/j.pec.2023.107886. Epub 2023 Jul 7.

  PMID: 37567038 DERIVED

• 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.

  PMID: 27923864 DERIVED

• 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.

  PMID: 27839954 DERIVED

• 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.

  PMID: 21999719 DERIVED

• 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.

  PMID: 21382516 DERIVED

• 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.

  PMID: 19373517 DERIVED

• 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.

  PMID: 18838243 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

A limitation of this study is the low completion rate of smokers enrolling in the study. This increases the chance of accepting the null hypothesis when there may be differences between groups if all smokers had provided their outcomes.

Results Point of Contact

• Title: Dr. Geoffrey Williams
• Organization: University of Rochester

geoffrey_williams@urmc.rochester.edu

585-530-2050

Study Officials

• Geoffrey C Williams, MD, Ph.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 15, 2013
• Results First Posted: February 15, 2013

Record last verified: 2009-07

Locations

US (1)