# Enhancing an Intervention for Smokers with Chronic Pain using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans

> **NIH VA I01** · VA CONNECTICUT HEALTHCARE SYSTEM · 2024 · —

## Abstract

Background: Approximately 20% of Veterans smoke. Like smoking, pain is frequently reported by Veterans
and smoking is associated with concurrent pain intensity. A reciprocal biopsychosocial model of pain and
smoking is hypothesized whereby pain and smoking mutually maintain each other resulting in a cycle marked
by elevations in both. More than 50% of patients with chronic pain smoke and standard smoking cessation
interventions are largely ineffective for them – in part because pain is a trigger to smoke.
Significance: In a recently completed comparative effectiveness trial (IIR15-092), a standard smoking
cessation protocol (including pharmacotherapy) was compared to an integrated evidence-based pain and
smoking cessation intervention (PASS) among Veterans with chronic pain. At 6-month follow-up, 12% of the
patients in the PASS condition reported a 30-day point prevalence abstinence from smoking compared to 6%
in the standard protocol. The PASS condition also demonstrated a 6-month improvement in pain interference
(34% reported a 30% reduction in pain interference) compared to 19% in the standard protocol. Depressive
symptoms were found to have a significant moderating effect such that those with clinically meaningful
depression achieved a lower cessation rate relative to non-depressed (8% vs 17%). Though PASS was
significant (and promising), the intervention arm did not surpass the superiority threshold (15%) and it did not
achieve the expected 20% cessation rate. Accordingly, a more intense intervention is needed to optimize
smoking cessation among non-depressed Veterans with pain. Future efforts will then need to augment the
intervention for those who are depressed.
Innovation & Impact: This proposal augments the PASS intervention with Interactive Voice Response (IVR) to
optimize the effectiveness of the intervention. IVR allows patients to interact with a computer-operated phone
system and receive personalized asynchronous feedback to reinforce PASS skill acquisition, and utilization.
Specific Aims: AIM 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.
Hypotheses 1.1: Prolonged abstinence rates and point prevalence abstinence rates will be significantly higher
among non-depressed Veterans with chronic pain who receive PASS-IVR compared with those in E-TAU.
AIM 2: Determine whether PASS-IVR is superior to E-TAU at 6 (primary endpoint) and 12 months on pain
interference.
Hypothesis 2.1: Non-depressed Veterans in PASS-IVR will report significantly lower pain interference relative
to E-TAU.
AIM 3: Examine key components of the intervention process to inform future program implementation using the
RE-AIM framework which con...

## Key facts

- **NIH application ID:** 10861518
- **Project number:** 1I01HX003607-01A2
- **Recipient organization:** VA CONNECTICUT HEALTHCARE SYSTEM
- **Principal Investigator:** Lori A Bastian
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2024-06-01 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10861518

## Citation

> US National Institutes of Health, RePORTER application 10861518, Enhancing an Intervention for Smokers with Chronic Pain using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans (1I01HX003607-01A2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10861518. Licensed CC0.

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