Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579846
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Experimental Study to Evaluate the Efficacy in Tobacco AbstinEnce At 12 Months of DIrected Exercise and CyTisinicline
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
MEDSEC-CTA12
Brief Summary:
Current scientific evidence demonstrates the relationship between good physical fitness and a lower incidence of certain chronic diseases including smoking as well as the effectiveness of cytisinicline This protocol aims to evaluate the efficacy of the synergistic effect of combining structured physical exercise brief counseling and cytisinicline administration in achieving smoking cessation The study will be an experimental multicenter randomized and controlled trial with two parallel arms conducted by a multidisciplinary team within the primary care setting of the Andalusian public health system with a 12-month follow-up The estimated sample size is 75 participants per arm One of the study arms will include a structured exercise program aligned with the recently approved regional Andalusian health plan
Detailed Description:
None
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