Biopsychosocial Predictors of Nicotine Relapse
- Conditions
- SmokingSmoking CessationNicotine AddictionTobacco Smoking Behavior
- Registration Number
- NCT06470321
- Lead Sponsor
- University of Cyprus
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age 18-60 years
- Smoking at least 10 cigarettes daily for at least 2 years
- Intention to quit smoking
- Medication-free
- Presence of psychiatric or medical treatment
- Pregnancy
- Current unstable medical illness
- Recent (prior 6 months) drug or alcohol use disorder
- Major Depression
- Diagnosis of psychotic disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Time to First Smoking Lapse 6 months Defined as the number of days between the quit date and the first smoking lapse (smoking even a puff of a cigarette). Smoking lapses will be monitored continuously via self-report.
Maintenance of Abstinence Measured at 3 and 6 month follow-ups Defined as biochemically verified (via expired carbon monoxide) continuous abstinence from smoking for the full 6 month period after the quit date
- Secondary Outcome Measures
Name Time Method Withdrawal Symptoms Baseline, 24 hours Assessed via standardized withdrawal symptom questionnaires at baseline and after 24 hours of abstinence.
Stress Responses Baseline, 24 hours Salivary cortisol levels measured before and after stress exposure at baseline and 24-hour timepoints
Emotion Regulation Baseline, 24 hours Measured via heart rate variability before and after stress exposure at baseline and 24-hour timepoints
Neural Activity Baseline, 24 hours Quantitative EEG spectral power and coherence between brain regions involved in emotion regulation assessed at baseline and after 24-hour abstinence.