Identifying Biomarkers of Stress-induced Neurophysiological Changes and Emotion Regulation Deficits to Predict Relapse During Nicotine Abstinence

What this Trial Is About

Researchers are investigating how a person's ability to regulate emotions and changes in brain activity caused by stress affect their chances of relapse when trying to quit smoking. The study focuses on smokers aged 18 to 60 who smoke at least 10 cigarettes daily and intend to quit. It aims to understand how these psychological and biological factors influence cravings, adherence to abstinence, and response to a smoking cessation program. The study includes three main phases. First, participants continue smoking as usual while their emotion regulation, brain activity, stress responses, and cravings are measured before and after a stress task. Next, they abstain from smoking for 24 hours, during which these measures are repeated along with withdrawal symptoms and cue-induced cravings. Finally, participants use Flexiquit, a six-month avatar-led computerized smoking cessation program that offers motivational support, education on addiction, strategies to manage cravings, relapse prevention, and stress regulation skills. Abstinence is verified biochemically at three and six months after quitting. Participants will be involved in several assessments throughout the study, including heart rate variability, brain scans via quantitative electroencephalography, saliva tests for stress hormones, and questionnaires on cravings and withdrawal symptoms. Adherence to the cessation program is monitored, and researchers will track smoking lapses and time to relapse over six months. The main outcomes studied are maintaining abstinence and the timing of first smoking lapses, along with changes in emotion regulation and stress-related brain activity.

Biopsychosocial Predictors of Nicotine Relapse