Pain and Smoking Study 2 (PASS2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking; Smoking Cessation; Pain
• Intervention / Treatment: Other: Treatment as Usual; Behavioral: PASS2

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori A Bastian, MD MPH; Phone Number: 3830 (203) 932-5711; Email: Lori.Bastian@va.gov
• Study Contact Backup: Name: Mary Driscoll, PhD; Phone Number: 3631 (203) 932-5744; Email: Mary.Driscoll3@va.gov

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516-2770
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
      • Contact: Lori A Bastian, MD MPH; Phone Number: 3830 (203) 932-5711; Email: Lori.Bastian@va.gov
      • Principal Investigator: Lori Anne Bastian, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment as Usual; Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service	Other: Treatment as Usual; Referral to the local smoking cessation VA clinic.
Experimental: PASS2; 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. Veterans in PASS2 will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).	Behavioral: PASS2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette Smoking Abstinence Rates	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?"	10-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette Smoking Abstinence Rates	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?"	4-month follow up
Point prevalent abstinence	Patients will be asked "Have you have smoked at least part of a cigarette, even a puff, in the past 7 days?"	4-month and 10-month follow-up
Pain intensity and pain-related functional interference	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.	4-month and 10-month follow-up

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Lori Anne Bastian, MD MPH, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Health Behavior; Pain; Smoking; Smoking Cessation; Therapeutics
• Other Study ID Numbers: IIR 22-070 (Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No