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NCT Number: NCT06442514

Pain and Smoking Study 2

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.

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Key information

Conditions

Smoking Behavior Health Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

West Haven, Connecticut, 06516-2770, United States

Location contact

Lori A Bastian, MD MPH

CONTACT

[email protected]

(203) 932-5711 ext. 3830

Lori Anne Bastian, MD MPH

PRINCIPAL_INVESTIGATOR

About this study

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:

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.
Determine whether PASS2 is superior to E-TAU at 4 months and 10 months (primary endpoint) on pain interference.
Examine critical components of the intervention process to inform future program implementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PASS2

Behavioral

An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly surveys to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.

Treatment as Usual

Other

Referral to the local smoking cessation VA clinic.

Primary outcomes

Cigarette Smoking Abstinence Rates

Time frame: 10-month follow-up

In keeping with the SNRT recommendations for measuring abstinence, the investigators will use prolonged abstinence as our main outcome. During the 10-month follow-ups, patients will be asked about prolonged abstinence, "In the past 6 months, have you smoked a cigarette, even a puff?"

Secondary outcomes

Cigarette Smoking Abstinence Rates

Time frame: 4-month follow up

The investigators will measure prolonged abstinence at the 4-month follow up as a secondary outcome. During the 4-month follow-ups, patients will be asked about prolonged abstinence, "In the past 3 months have you smoked a cigarette, even a puff?"
Point prevalent abstinence

Time frame: 4-month and 10-month follow-up

Patients will be asked "Have you have smoked at least part of a cigarette, even a puff, in the past 7 days?"
Pain intensity and pain-related functional interference

Time frame: 4-month and 10-month follow-up

Pain intensity and interference will be assessed using the 11-item Brief Pain Inventory (BPI). The BPI also assesses chronicity of pain and areas of the body with pain. The interference subscale has demonstrated adequate internal consistency and robust concurrent validity and responsivity among patients with chronic non-cancer pain. The investigators have also added the PROMIS 8-item pain interference measure and the PROMIS 3-item pain intensity measure which has comparable responsiveness to BPI and excellent internal consistency.

Study contacts

Contact information is provided by the study sponsor or research team.

Lori A Bastian, MD MPH

CONTACT

[email protected]

(203) 932-5711 ext. 3830

Mary Driscoll, PhD

CONTACT

[email protected]

(203) 932-5744 ext. 3631

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: PASS2

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 4, 2024
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed