Biopsychosocial Predictors of Nicotine Relapse

NCT06470321 | Recruiting

• 1 other identifier: 101031962
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation; Nicotine Addiction; Tobacco Smoking Behavior

Keywords

Nicotine; Relapse; Vulnerability; Biomarkers; EEG; HRV; Stress Reactivity

Outcome Measures

Primary Outcomes (2)

• Maintenance of Abstinence

  Defined as biochemically verified (via expired carbon monoxide) continuous abstinence from smoking for the full 6 month period after the quit date

  Measured at 3 and 6 month follow-ups

• Time to First Smoking Lapse

  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.

  6 months

Secondary Outcomes (4)

• Withdrawal Symptoms

  Baseline, 24 hours

• Emotion Regulation

  Baseline, 24 hours

• Neural Activity

  Baseline, 24 hours

• Stress Responses

  Baseline, 24 hours

Study Arms (1)

Smoking Cessation Intervention

EXPERIMENTAL

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.

Behavioral: Flexiquit Computerized Smoking Cessation Program

Interventions

Flexiquit Computerized Smoking Cessation Program BEHAVIORAL

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.

Smoking Cessation Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Smoking at least 10 cigarettes daily for at least 2 years
• Intention to quit smoking
• Medication-free

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cyprus: lead

Study Sites (1)

Center for Applied Neuroscience

Nicosia, 2100, Cyprus

RECRUITING

Related Publications (2)

• 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.

  PMID: 28845999 BACKGROUND

• 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.

  PMID: 32383736 BACKGROUND

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Disorder; Recurrence

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Panos Zanos, Ph.D.

CONTACT

+35722892243; zanos.panos@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neuropharmacology

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: January 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)