Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT04061720
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2019-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Status:
COMPLETED
Status Verified Date:
2025-09
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:
None
Brief Summary:
This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: use of cessation treatment and smoking abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.
Detailed Description:
This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: smoking treatment reach (use of cessation treatment) and abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.
The investigators will evaluate these interventions using a 2-arm randomized controlled trial. Veterans who smoke daily, but who are not willing to enter smoking cessation treatment, will be eligible to participate, with no obligation to quit smoking. Participants (N=500) will be randomized to one of the following treatments: 1) Enhanced Chronic Care (n=250) or 2) Standard Care (n=250). These intervention conditions will last 2 years to permit analysis of their cumulative impact on abstinence and treatment use
The investigators will evaluate these interventions using a 2-arm randomized controlled trial. Veterans who smoke daily, but who are not willing to enter smoking cessation treatment, will be eligible to participate, with no obligation to quit smoking. Participants (N=500) will be randomized to one of the following treatments: 1) Enhanced Chronic Care (n=250) or 2) Standard Care (n=250). These intervention conditions will last 2 years to permit analysis of their cumulative impact on abstinence and treatment use
Study Oversight
Has Oversight DMC:
False
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?: