Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609369
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects
Detailed Description:
The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions when combined with varenicline medication in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms The secondary objective of this study is to examine sex differences
Investigators will recruit from two primary sources 1 community-based recruitment strategies including web and social media ads lay community members to recruit and local communication channels 2 investigators will invite referred patients to the outpatient Tobacco Treatment Service TTS at Yale-New Haven Hospital
All participants will be assigned to one of two behavioral interventions Both groups will receive treatment with varenicline and attend weekly individual counseling sessions standard care or cognitive behavioral therapy for insomnia and wear research-grade sleep actiwatches for passive sleep monitoring
Participants will have a total of five expected research visits with a scheduled target quit date for Week 4 Participants will undergo MRI at baseline and at Week 4 and attend follow-ups at week 8 12 and 26
Investigators will recruit from two primary sources 1 community-based recruitment strategies including web and social media ads lay community members to recruit and local communication channels 2 investigators will invite referred patients to the outpatient Tobacco Treatment Service TTS at Yale-New Haven Hospital
All participants will be assigned to one of two behavioral interventions Both groups will receive treatment with varenicline and attend weekly individual counseling sessions standard care or cognitive behavioral therapy for insomnia and wear research-grade sleep actiwatches for passive sleep monitoring
Participants will have a total of five expected research visits with a scheduled target quit date for Week 4 Participants will undergo MRI at baseline and at Week 4 and attend follow-ups at week 8 12 and 26
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None