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

This study has been completed.
Sponsor:
Collaborators:
New York State Department of Health
Greater Rochester Area Tobacco Cessation Center
Health Maintenance Consortium
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178685
First received: September 13, 2005
Last updated: January 15, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Behavioral: Self-determination Intervention for Tobacco Dependence
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-determination and Maintaining Tobacco Abstinence

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. [ Time Frame: 12 months after subject completes intervention. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 7 Day Point Prevelence (7DPP) [ Time Frame: 12 months after the intervention ] [ Designated as safety issue: No ]
    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.


Enrollment: 837
Study Start Date: August 2004
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Self-determination Intervention for Tobacco Dependence
    autonomy supported behavioral intervention for tobacco dependent individuals
    Other Name: Smokers' Health 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178685

Locations
United States, New York
Smokers' Health Project
Rochester, New York, United States, 14607
Sponsors and Collaborators
University of Rochester
New York State Department of Health
Greater Rochester Area Tobacco Cessation Center
Health Maintenance Consortium
Investigators
Principal Investigator: Geoffrey C Williams, MD, Ph.D. University of Rochester
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geoffrey C Williams, University of Rochester, Smokers' Health Project
ClinicalTrials.gov Identifier: NCT00178685     History of Changes
Other Study ID Numbers: 10085, R01 CA10666, 1R21CA119112-01A2
Study First Received: September 13, 2005
Results First Received: January 15, 2013
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Self-determination
motivation
adherence
competence
autonomy
tobacco dependence
Tobacco use and dependence
Behavior change

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014