Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442514
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-29
Brief Title:
Pain and Smoking Study - Interactive Voice Response
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Enhancing an Intervention for Smokers With Chronic Pain Using IVR A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans
Status:
NOT_YET_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:
PASS-IVR
Brief Summary:
PASS2 aims to expand upon the recently completed study PASS intervention which tested the telephone delivery of a cognitive behavioral intervention CBI This study will use Interactive Voice Response IVR to optimize the interventions effectiveness for smoking cessation among Veteran smokers with chronic pain
Detailed Description:
Veterans with chronic pain represent an important population in which to focus smoking cessation efforts Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality yet many patients 50 with chronic pain continue to smoke
This study aims to
1 Determine whether the existing integrated pain and smoking cessation PASS intervention augmented with IVR PASS-IVR is superior to treatment as usual eg referral to standard VA smoking cessation clinic enhanced with pharmacotherapy tele-consult E-TAU at 6 primary endpoint and 12 months on cigarette abstinence rates among non-depressed Veterans with chronic pain
2 Determine whether PASS-IVR is superior to E-TAU at 6 primary endpoint and 12 months on pain interference
3 Examine critical components of the intervention process to inform future program implementation
This study aims to
1 Determine whether the existing integrated pain and smoking cessation PASS intervention augmented with IVR PASS-IVR is superior to treatment as usual eg referral to standard VA smoking cessation clinic enhanced with pharmacotherapy tele-consult E-TAU at 6 primary endpoint and 12 months on cigarette abstinence rates among non-depressed Veterans with chronic pain
2 Determine whether PASS-IVR is superior to E-TAU at 6 primary endpoint and 12 months on pain interference
3 Examine critical components of the intervention process to inform future program implementation
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