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NCT06442514NARecruiting

Pain and Smoking Study 2.0: A Randomized Clinical Trial of Smoking Cessation Among Veterans With Chronic Pain

VA Office of Research and Development

Start Date

9/21/2026

Completion Date

5/31/2028

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 nightly surveys 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 nightly surveys (PASS2) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 4 months and 10 months (primary endpoint) on cigarette abstinence rates among non-depressed Veterans with chronic pain. 2. Determine whether PASS2 is superior to E-TAU at 4 months and 10 months (primary endpoint) on pain interference. 3. Examine critical components of the intervention process to inform future program implementation.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * being an enrolled Veteran at VACHS * current tobacco use * willingness to make a quit attempt * significant chronic pain defined as \>/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days Exclusion Criteria: * active diagnosis of dementia or psychosis in medical record * severely impaired hearing or speech * lack of telephone access * enrollment in concurrent research study that might affect main outcomes of this study * terminal illness * non-English speaking * pregnancy * provider advising against exercise * planned surgeries * clinically significant depressive symptoms (\>10 PHQ-9)

Interventions

BEHAVIORAL

PASS2

OTHER

Treatment as Usual

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Conditions

SmokingPainSmoking Cessation

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut 06516-2770

United States