Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470321
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Biopsychosocial Predictors of Nicotine Relapse
Sponsor:
University of Cyprus
Organization:
University of Cyprus
Study Overview
Official Title:
Identifying Biomarkers of Stress-induced Neurophysiological Changes and Emotion Regulation Deficits to Predict Relapse During Nicotine Abstinence
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioNic
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None