Pain and Smoking Study - Interactive Voice Response

NCT ID: NCT06442514

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-30
• Study Completion Date: 2028-05-31

Brief 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 Interactive Voice Response (IVR) 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 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.

2. Determine whether PASS-IVR is superior to E-TAU at 6 (primary endpoint) and 12 months on pain interference.

3. Examine critical components of the intervention process to inform future program implementation.

Conditions

Smoking; Pain; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

Treatment as Usual

Intervention Type: OTHER

Referral to the local smoking cessation VA clinic.

PASS-IVR

An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls. Veterans in PASS-IVR 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).

Group Type: EXPERIMENTAL

PASS-IVR

Intervention Type: 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 Interactive Voice Response (IVR) calls to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.

Interventions

PASS-IVR

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

Intervention Type: BEHAVIORAL

Treatment as Usual

Referral to the local smoking cessation VA clinic.

Intervention Type: OTHER

Eligibility 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; and
• clinically significant depressive symptoms (>10 PHQ-9).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Anne Bastian, MD MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

West Haven, Connecticut, United States

Countries

United States

Central Contacts

Lori A Bastian, MD MPH

Role: CONTACT

Lori.Bastian@va.gov

(203) 932-5711 ext. 3830

Mary Driscoll, PhD

Role: CONTACT

Mary.Driscoll3@va.gov

(203) 932-5744 ext. 3631

Facility Contacts

Lori A Bastian, MD MPH

Role: primary

Lori.Bastian@va.gov

(203) 932-5711 ext. 3830

Other Identifiers

IIR 22-070

Identifier Type: -

Identifier Source: org_study_id