Pain and Smoking Study - Interactive Voice Response

NCT06442514 | Not Yet Recruiting DMC

• 1 other identifier: IIR 22-070
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Pain; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Cigarette Smoking Abstinence Rates

  In keeping with the SNRT recommendations for measuring abstinence, we will use prolonged abstinence as our main outcome and allow for a grace period around quit date. During the 6- and 12-month follow-ups, patients will be asked about prolonged abstinence, "Since \[end of the grace period\] have you ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After \[end of the grace period\] have you smoked any in each of 2 consecutive weeks".

  6-month and 12-month follow-up

Secondary Outcomes (2)

• Point prevalent abstinence

  6-month and 12-month follow-up

• Pain intensity and pain-related functional interference

  baseline, 6-months follow-up, and 12-months follow-up

Study Arms (2)

PASS-IVR

EXPERIMENTAL

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).

Behavioral: PASS-IVR

Treatment as Usual

OTHER

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

Interventions

PASS-IVR 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.

PASS-IVR

Treatment as Usual OTHER

Referral to the local smoking cessation VA clinic.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Smoking; Pain; Smoking Cessation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior

Study Officials

• Lori Anne Bastian, MD MPH

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori A Bastian, MD MPH

CONTACT

(203) 932-5711; Lori.Bastian@va.gov

Mary Driscoll, PhD

CONTACT

(203) 932-5744; Mary.Driscoll3@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)