Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Pain and Smoking: A Program to Help Veterans Quit Smoking with Chronic Pain

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

Run by VA Office of Research and Development · NCT06442514 · Data updated 2026-11-12

This study tests whether the PASS2 program, which adds nightly surveys to a pain-and-smoking cessation intervention, helps Veterans with chronic pain quit smoking better than usual care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment220 (estimated)
SponsorVA Office of Research and Development
Federal
Locations1 site (West Haven, Connecticut)
StatusRecruiting
StartedSeptember 21, 2026
Main results expectedMay 31, 2028
Study endsMay 31, 2028
Registry record updatedSeptember 29, 2026
Trial IDNCT06442514 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Enrolled Veterans at VACHS who currently smoke, are willing to quit, and have significant chronic pain (BPI pain intensity ≥4 for ≥90 days).

Probably not a fit

Individuals with severe depressive symptoms, cognitive impairment, or other exclusion criteria may not experience benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PASS2 expands on a prior intervention by adding nightly surveys to support smoking cessation in Veterans who have chronic pain. The trial compares PASS2 to standard care (referral to a VA smoking cessation clinic) with pharmacotherapy tele-consult, tracking abstinence at 4 and 10 months. It also compares PASS2 to standard care on pain interference and aims to identify which parts of the intervention are most important for implementation. Eligible participants are enrolled Veterans with current tobacco use, significant chronic pain, and no exclusion criteria such as dementia, active psychosis, or lack of telephone access. The study is conducted at the VA Connecticut Healthcare System West Haven Campus.

Why it matters

Potential benefit: If successful, PASS2 could improve smoking abstinence rates and reduce pain-related interference in daily life for Veterans with chronic pain.

How similar studies have gone: Prior work with the PASS intervention showed promise, and PASS2 builds on that approach by adding nightly surveys to optimize outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    West Haven, Connecticut, United States
    Recruiting

Study contacts

  • Principal investigator: Lori Anne Bastian, MD MPH — VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Study coordinator: Lori A Bastian, MD MPH
  • Email: Lori.Bastian@va.gov
  • Phone: (203) 932-5711

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.