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Self-determination and Maintaining Tobacco Abstinence

Phase 4
18 Years
Not Enrolling
Tobacco Use Disorder

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Trial Information

Self-determination and Maintaining Tobacco Abstinence

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.

Outcome Description:

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.

Outcome Time Frame:

12 months after subject completes intervention.

Safety Issue:


Principal Investigator

Geoffrey C Williams, MD, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

August 2008

Related Keywords:

  • Tobacco Use Disorder
  • Self-determination
  • motivation
  • adherence
  • competence
  • autonomy
  • tobacco dependence
  • Tobacco use and dependence
  • Behavior change
  • Tobacco Use Disorder



Smokers' Health Project Rochester, New York  14607