SmokingBioNicNCT06470321
Biopsychosocial Predictors of Nicotine Relapse
A study testing Flexiquit Computerized Smoking Cessation Program in people with Smoking and Smoking Cessation, run by University of Cyprus at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Smoking, Smoking Cessation, Nicotine Addiction
- What is being tested?
- Flexiquit Computerized Smoking Cessation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jan 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Smoking at least 10 cigarettes daily for at least 2 years
- Intention to quit smoking
- Medication-free
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Center for Applied Neuroscience
Nicosia, 2100
Panos Zanos, Ph.D., zanos.panos@ucy.ac.cy
Panos Zanos, Ph.D.
About this study
Official title: Identifying Biomarkers of Stress-induced Neurophysiological Changes and Emotion Regulation Deficits to Predict Relapse During Nicotine Abstinence
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.
Read the 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.
- Being tested
- Flexiquit Computerized Smoking Cessation Program
- Keywords
- Nicotine, Relapse, Vulnerability, Biomarkers, EEG, HRV, Stress Reactivity
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use Disorder, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexiquit Computerized Smoking Cessation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Flexiquit Computerized Smoking Cessation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: 6 months
Secondary outcomes (4)
Withdrawal Symptoms
Assessed via standardized withdrawal symptom questionnaires at baseline and after 24 hours of abstinence.
Measured: Baseline, 24 hours
Emotion Regulation
Measured via heart rate variability before and after stress exposure at baseline and 24-hour timepoints
Measured: Baseline, 24 hours
Neural Activity
Quantitative EEG spectral power and coherence between brain regions involved in emotion regulation assessed at baseline and after 24-hour abstinence.
Measured: Baseline, 24 hours
Stress Responses
Salivary cortisol levels measured before and after stress exposure at baseline and 24-hour timepoints
Measured: Baseline, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jan 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panos Zanos, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470321
- Sponsor's protocol ID
- 101031962
- Other IDs
- 101031962
- Acronym
- BioNic
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28845999Karekla 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.
PubMed 32383736
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers of Stress-induced Neurophysiological Changes and Emotion Regulation Deficits to Predict Relapse During Nicotine Abstinence
- ClinicalTrials.gov ID
- NCT06470321
- Acronym / sponsor ID
- BioNic / 101031962
- Keywords
- Nicotine, Relapse, Vulnerability, Biomarkers, EEG, HRV, Stress Reactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Intervention | Experimental | Behavioral: Flexiquit Computerized Smoking Cessation ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- Smoking at least 10 cigarettes daily for at least 2 years
- Intention to quit smoking
- Medication-free
Key exclusion criteria (6 listed)
- Presence of psychiatric or medical treatment
- Pregnancy
- Current unstable medical illness
- Recent (prior 6 months) drug or alcohol use disorder
- Major Depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexiquit Computerized Smoking Cessation ProgramFlexiquit 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. | Behavioural | Smoking Cessation Intervention |
Primary outcome
Maintenance of Abstinence
Time frame: 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
Time frame: 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.
4 secondary outcomes
Withdrawal Symptoms
Time frame: Baseline, 24 hours
Emotion Regulation
Time frame: Baseline, 24 hours
Neural Activity
Time frame: Baseline, 24 hours
Stress Responses
Time frame: Baseline, 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Background: PubMed 28845999Karekla 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.
- Background: PubMed 32383736Karekla 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexiquit Computerized Smoking Cessation Program in people with Smoking and Smoking Cessation, run by University of Cyprus at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panos Zanos, Ph.D. (+35722892243, zanos.panos@ucy.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of Abstinence (time frame: Measured at 3 and 6 month follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06470321, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.