The study will assess whether an extended period of one-on-one counseling — after an initial phase of counseling plus FDA-approved cessation medications — is more successful in helping smokers kick the habit.
In 2009 there were an estimated 46 million smokers in the United States, according to the Centers for Disease Control and Prevention. Statistics from the American Cancer Society indicate that tobacco use is linked to one in five deaths from causes such as cancer, heart disease, aneurysms, emphysema and stroke.
Sean David, MD, DPhil, clinical associate professor of medicine and the principal investigator for the study, said only a relatively small percentage of smokers who attempt to quit on their own have long-term success.
With the Great American Smokeout taking place on Nov. 17 and the time drawing near when people make new year’s resolutions to change bad habits, many smokers may be looking for options to help them quit for good.
“Relapse following treatment for nicotine dependence continues to be a problem for a lot of smokers,” David said. “We want to find out whether providing support over a longer period of time is a more successful strategy.”
For the study, participants will undergo six months of one-on-one cognitive behavioral therapy in which they will learn strategies to help them decrease their nicotine cravings, develop alternatives to smoking and learn coping skills to resist cigarettes in high-risk situations. Additionally, they will be provided with smoking-cessation medications.
At the end of six months, the participants will be randomly assigned to one of two groups. The first will continue to receive individual counseling sessions for another six months, while the second will receive monthly follow-up phone calls for the same period of time. The frequency of the counseling sessions will decline over the course of the study. “We want them to learn how to be more self-reliant and self-confident in controlling their behavior,” David said.
The researchers will assess both groups at the one-year mark, and will also follow up on the participants two years after they enrolled in the study.
The researchers are recruiting 400 smokers between the ages of 18 and 65 who smoke at least 10 cigarettes a day. Because the clinic visits and therapy sessions will take place in San Jose, the study is open to those who live in Santa Clara County and parts of San Mateo and Alameda counties.
Potential participants will go through a screening that includes a free physical exam to determine their eligibility for the study. All medications and therapy will be provided at no cost.
For information on the trial, contact the research team at (877) 331-3352 or firstname.lastname@example.org.
The study is funded by the National Institute on Drug Abuse.