An innovative smoking cessation research study moves from the Mayo Clinic to the UTHSC Department of Preventive Medicine, where researchers are looking for 275 smokers to participate in a new approach called Step.
Researchers at the University of Tennessee Health Science Center (UTHSC) Department of Preventive Medicine are looking for 275 smokers to participate in a new approach to smoking cessation called Step. A total of 400 adult smokers will be enrolled in the study. The study commenced at Mayo Clinic in Rochester, Minn., where approximately 136 participants were recruited. Recruitment ceased at Mayo Clinic when the study moved to UTHSC; however, participants will continue to be followed for two years.
Cigarette smokers who are 18 years of age or older, in relatively good health, who self-report smoking at least 10 cigarettes each day, and who are willing to accept random assignment are eligible to participate. Participants must agree to commit to the study for at least 24 months following screening. One of the major problems in achieving long-term behavior change with smoking cessation is that smoking relapse rates are alarmingly high. Of those who make a serious attempt to quit, over half (58%) have resumed smoking within a two-week period.
The current study will investigate what is a common medical approach to treatment, namely a “stepped care” approach to smoking cessation. There will be two different comparisons in this study. Both comparisons start with an effective behavioral stop-smoking program. All participants will also be given the nicotine patch at no charge to help them quit. After six months, if participants have either not quit smoking or have relapsed, participants in one condition will get the interventions repeated while in the other, they will receive more aggressive behavioral and pharmacologic intervention (i.e., four sessions of behavioral counseling and bupropion). After 12 months, participants who are still smoking, depending on the group they are randomly assigned to, will again either have the intervention repeated or get a more intensive intervention (six sessions of behavioral intervention, plus the patch, plus nicotine chewing gum). It is important to note that all participants, regardless of the group they are assigned to, get an effective stop-smoking program plus free pharmacologic intervention for smoking cessation.
The principal investigator for the study at UTHSC is Robert C. Klesges. PhD. Dr. Klesges has a 20-year history of conducting important clinical trials for smoking cessation and obesity in Memphis. He also serves as the principal investigator for a large National Heart Lung Blood Institute-funded study being run at the St. Jude Children’s Research Hospital. Co-Investigators on the Step-Care study are Mark Vander Weg, PhD, Georgeta Vaidean, MD, MPH, PhD, Grant Somes, PhD, and Kathy Ryder, MD. Other key study personnel include, Neysa Rhoads, RN, BS, CCRC, and DarrelI Jackson, RN. The study sponsor is the National Cancer Institute.
Anyone interested in participating in the Step research study should call the UTHSC Preventive Medicine recruitment department at 901-448-8400 or 1-800-916-2606 to determine eligibility.