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.