Health TrialsbyHealthPanel

Biopsychosocial Predictors of Nicotine Relapse

ConditionsSmokingSmoking CessationNicotine AddictionTobacco Smoking Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Cyprus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-60 years

Smoking at least 10 cigarettes daily for at least 2 years

Intention to quit smoking

Medication-free

Disqualifiers

Presence of psychiatric or medical treatment

Pregnancy

Current unstable medical illness

Recent (prior 6 months) drug or alcohol use disorder

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Smoking Cessation InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Measured at 3 and 6 month follow-ups
2

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.

Time frame
6 months

Secondary outcomes

1

Withdrawal Symptoms

Assessed via standardized withdrawal symptom questionnaires at baseline and after 24 hours of abstinence.

Time frame
Baseline, 24 hours
2

Emotion Regulation

Measured via heart rate variability before and after stress exposure at baseline and 24-hour timepoints

Time frame
Baseline, 24 hours
3

Neural Activity

Quantitative EEG spectral power and coherence between brain regions involved in emotion regulation assessed at baseline and after 24-hour abstinence.

Time frame
Baseline, 24 hours
4

Stress Responses

Salivary cortisol levels measured before and after stress exposure at baseline and 24-hour timepoints

Time frame
Baseline, 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cyprus

Lead sponsor

Source ClinicalTrials.gov
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