Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-01-01
2025-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Smoking Cessation Intervention
Participants receive Flexiquit, an avatar-led computerized smoking cessation program. Flexiquit is a self-delivered app providing: motivational interviewing, psychoeducation on addiction/withdrawal, cognitive-behavioral strategies for cravings, relapse prevention, stress/emotion regulation skills. Delivered over 6 months starting Day 2 after initial assessments. Adherence monitored. Biochemical verification of abstinence at 3 and 6 months post-quit.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Smoking at least 10 cigarettes daily for at least 2 years
* Intention to quit smoking
* Medication-free
Exclusion Criteria
* Pregnancy
* Current unstable medical illness
* Recent (prior 6 months) drug or alcohol use disorder
* Major Depression
* Diagnosis of psychotic disorder
18 Years
60 Years
ALL
No
Sponsors
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University of Cyprus
OTHER
Responsible Party
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Panos Zanos
Assistant Professor of Neuropharmacology
Locations
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Center for Applied Neuroscience
Nicosia, , Cyprus
Countries
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Central Contacts
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Facility Contacts
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Panos Zanos, Ph.D.
Role: backup
References
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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.
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.
Other Identifiers
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101031962
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
101031962
Identifier Type: -
Identifier Source: org_study_id
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