Personalized Smoking Cessation Using Nicotine Replacement, Varenicline, Bupropion, and Counseling PISCES I Phase IV Trial Evaluating Treatment Effects and Rescue Options

What this Trial Is About

Researchers are studying how to personalize smoking cessation treatments, including medications and counseling, based on each persons unique traits. This phase IV trial focuses on therapies such as nicotine replacement therapy NRT, varenicline, and bupropion, aiming to help participants quit smoking or change their smoking habits. The study also looks to improve treatment plans for those who do not quit after initial therapy. Participants are randomly assigned to one of two groups one group receives varenicline daily or twice daily for six weeks plus counseling, and the other group receives nicotine replacement therapy patch, lozenges, or gum plus counseling for six weeks. Those who quit continue their assigned treatment for an additional six weeks. After six weeks, participants who have not quit smoking are re-randomized into one of five groups with varied strategies, including continuing current therapy, switching treatments, increasing doses, adding bupropion, or combining varenicline and NRT, all alongside counseling. Throughout the study, participants are followed up at three and six months after starting treatment. Researchers assess smoking status through measures like carbon monoxide levels and abstinence at twelve weeks. They also track relapse timing. Participants complete questionnaires and receive behavioral counseling. The study includes regular monitoring for safety and treatment adherence, with a total participation period extending up to six months.

Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial