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

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ClinicalTrials.gov Identifier: NCT00178685
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
New York State Department of Health
Greater Rochester Area Tobacco Cessation Center
Health Maintenance Consortium
National Institutes of Health (NIH)
Information provided by:
University of Rochester

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE January 15, 2013
Results First Posted Date  ICMJE February 15, 2013
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE August 2004
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. [ Time Frame: 12 months after subject completes 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
12 month prolonged abstinence from tobacco measured at 24 months from randomization.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
7 Day Point Prevelence (7DPP) [ Time Frame: 12 months after the intervention ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Tobacco abstinence measured as a latent variable with the following three indicators: longest number of days not smoking, the number of days since last cigarette, and the 12 month prolonged abstinence.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence
Official Title  ICMJE Self-determination and Maintaining Tobacco Abstinence
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE Behavioral: Self-determination Intervention for Tobacco Dependence
autonomy supported behavioral intervention for tobacco dependent individuals
Other Name: Smokers' Health Project
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2009)
837
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
950
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00178685
Other Study ID Numbers  ICMJE 10085
R01 CA10666
1R21CA119112-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Geoffrey C Williams, University of Rochester, Smokers' Health Project
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • New York State Department of Health
  • Greater Rochester Area Tobacco Cessation Center
  • Health Maintenance Consortium
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Geoffrey C Williams, MD, Ph.D. University of Rochester
PRS Account University of Rochester
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP