Clinical trial NCT06442514: Pain and Smoking Study - Interactive Voice Response
Official title: Enhancing an Intervention for Smokers With Chronic Pain Using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking
Pain
Smoking Cessation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-06-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Cigarette Smoking Abstinence Rates
timeFrame: 6-month and 12-month follow-up
Secondary outcomes:
measure: Point prevalent abstinence
timeFrame: 6-month and 12-month follow-up
measure: Pain intensity and pain-related functional interference
timeFrame: baseline, 6-months follow-up, and 12-months follow-up
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Lori Anne Bastian, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: