NCT06470321

Biopsychosocial Predictors of Nicotine Relapse

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Cyprus · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the associations between emotion regulation ability, stress-induced neural activity changes, and susceptibility to relapse in smokers attempting to quit. Participants will undergo assessments of emotion regulation, neural activity via quantitative electroencephalography (qEEG), and stress responses before and during a 24-hour nicotine abstinence period. They will then participate in a computerized smoking cessation intervention, and their abstinence status will be monitored for 6 months.

Detailed description

The study will examine the unique and interactive effects of emotion regulation ability (a trait-like vulnerability factor) and biomarkers of stress responses (emotion regulation and neural activation changes) prior to smoking cessation, on cravings, abstinence adherence, and response to a smoking cessation intervention. The study will be divided into three main phases: * Ad libitum nicotine use (Day 1): Participants will smoke as usual. Baseline assessments of emotion regulation (heart rate variability), neural activity (qEEG), stress responses (salivary cortisol), and nicotine craving will be conducted before and after exposure to a stress task. * Acute 24-hour abstinence (Day 2): Participants will abstain from smoking for 24 hours. Emotion regulation, neural activity, withdrawal symptoms, and cue-induced cravings will be assessed. * Smoking cessation intervention (Days 3 to 180): Participants will engage in a computerized smoking cessation program. Abstinence will be biochemically verified at 3 and 6 months post-quit. Smoking lapses and time to relapse will also be monitored. The primary outcomes are maintenance of abstinence, smoking lapses, and time to relapse. Secondary outcomes include changes in emotion regulation, neural activity, stress responses, withdrawal symptoms, and cue-induced cravings. The study hypothesizes that smokers who fail to maintain long-term abstinence will exhibit enhanced stress-induced high-frequency qEEG oscillations, disrupted connectivity in emotion regulation brain regions, and emotion regulation deficits. It is also hypothesized that the interplay between these measures will predict smoking cessation outcomes.

Conditions

• Smoking
• Smoking Cessation
• Nicotine Addiction
• Tobacco Smoking Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Flexiquit Computerized Smoking Cessation Program	Flexiquit is an avatar-led, self-directed computerized program delivering evidence-based techniques to assist with smoking cessation. It includes motivational interviewing, psychoeducation on nicotine addiction, cognitive-behavioral strategies for coping with cravings, relapse prevention, and stress/emotion regulation skills training. Participants receive the program over 6 months and their adherence is monitored. The program provides tailored feedback to support abstinence.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: Cyprus