Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy A Randomized Controlled Trial

What this Trial Is About

Researchers are studying the effects of smoking cessation in people with Substance Use Disorders (SUD), including alcohol use disorder and nicotine addiction. Smoking worsens health and complicates SUD treatment, so this study aims to explore whether quitting smoking can improve emotional regulation, reduce cravings, and enhance self-efficacy. The trial also investigates changes in metabolism and gut microbiome linked to brain reward systems, comparing individuals receiving treatment to healthy controls. Participants are randomly assigned to one of three groups: a six-week cognitive-behavioral therapy (CBT) smoking cessation program within a therapeutic community, a treatment as usual (TAU) group receiving long-term rehabilitation drug treatment and various therapies, or a healthy control group with no intervention. The CBT program includes weekly 1.5-hour sessions focused on education, relapse prevention, motivation, and behavior observation. TAU includes group therapy, individual psychotherapy, counseling, psychiatric consultations, and therapeutic community activities. Throughout the study, participants undergo blood and stool sample collection to analyze metabolomic and microbiome changes, alongside psychological assessments via questionnaires. Outcomes measured include self-efficacy, substance craving, tobacco dependence, mood, and smoking behavior from enrollment through a three-month follow-up after the intervention. Safety and psychiatric symptoms are also monitored. The healthy control group is assessed once to compare biological and psychological profiles. The total participant involvement spans the 6-week intervention plus a 3-month follow-up.

Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community