Clinical trial NCT06470321: Biopsychosocial Predictors of Nicotine Relapse
Official title: Identifying Biomarkers of Stress-induced Neurophysiological Changes and Emotion Regulation Deficits to Predict Relapse During Nicotine Abstinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Smoking Cessation
Nicotine Addiction
Tobacco Smoking Behavior
Keywords: Nicotine
Relapse
Vulnerability
Biomarkers
EEG
HRV
Stress Reactivity
Lead sponsor: University of Cyprus
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maintenance of Abstinence
timeFrame: Measured at 3 and 6 month follow-ups
measure: Time to First Smoking Lapse
timeFrame: 6 months
Secondary outcomes:
measure: Withdrawal Symptoms
timeFrame: Baseline, 24 hours
measure: Emotion Regulation
timeFrame: Baseline, 24 hours
measure: Neural Activity
timeFrame: Baseline, 24 hours
measure: Stress Responses
timeFrame: Baseline, 24 hours
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Center for Applied Neuroscience
Study officials:
References:
citation: Karekla M, Panayiotou G, Collins BN. Predictors of urge to smoke under stressful conditions: An experimental investigation utilizing the PASAT-C task to induce negative affect in smokers. Psychol Addict Behav. 2017 Nov;31(7):735-743. doi: 10.1037/adb0000309. Epub 2017 Aug 28.
citation: Karekla M, Savvides SN, Gloster A. An Avatar-Led Intervention Promotes Smoking Cessation in Young Adults: A Pilot Randomized Clinical Trial. Ann Behav Med. 2020 Oct 1;54(10):747-760. doi: 10.1093/abm/kaaa013.