NCT06442514

Pain and Smoking Study - Interactive Voice Response

Enhancing an Intervention for Smokers With Chronic Pain Using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 intervention's 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 (e.g., 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.

Conditions

• Smoking
• Pain
• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	PASS-IVR	An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.
OTHER	Treatment as Usual	Referral to the local smoking cessation VA clinic.

Timeline

• Start date: 2026-03-30
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2024-06-04
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States