Nicotine Addiction, Smoking, Smoking Cessation, Tobacco Smoking Behavior
Conditions
Keywords
Nicotine, Relapse, Vulnerability, Biomarkers, EEG, HRV, Stress Reactivity
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.
Interventions
BEHAVIORALFlexiquit 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.
Sponsors
University of Cyprus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Intervention Model: Single Group Assignment This is a single-arm study where all participants will receive the same smoking cessation intervention after completing the initial assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 years * Smoking at least 10 cigarettes daily for at least 2 years * Intention to quit smoking * Medication-free
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal Symptoms | Baseline, 24 hours | Assessed via standardized withdrawal symptom questionnaires at baseline and after 24 hours of abstinence. |
| 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. |
| Stress Responses | Baseline, 24 hours | Salivary cortisol levels measured before and after stress exposure at baseline and 24-hour timepoints |
Countries
Cyprus
Contacts
Primary ContactPanos Zanos, Ph.D.
Outcome results
None listed