Pain and Smoking Study (PASS)

VA Office of Research and Development

Status: Completed

Conditions: Pain; Smoking; Smoking Cessation

Treatments: Behavioral: Smoking Cessation Standard; Behavioral: Smoking Cessation plus CBI

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02971137

IIR 15-092

Details and patient eligibility

About

This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain

Full 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 test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain. Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with chronic pain will be randomized to either: 1) smoking cessation plus CBI (SMK-CBI), an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK Control), a contact-equivalent control that provides standard smoking cessation telephone counseling and a tele-medicine clinic for accessing NRT.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veterans enrolled at VA Connecticut or VA Central Western Massachusetts
• Current Cigarette Smokers
• Willing to make quit attempt in next 30 days
• Pain intensity 4 or greater on scale 0-10, self-reported

Exclusion criteria

• Non-English speaking
• No access to telephone/Lack of Telephone Access
• Severely impaired hearing
• Active diagnosis
• Terminal Illness
• Refusal to provide informed consent
• Enrolled in concurrent smoking cessation programs/research

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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371 participants in 2 patient groups

Smoking Cessation plus CBI (SMK-CBI)

Experimental group

Description:

An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain

Treatment:

Behavioral: Smoking Cessation plus CBI

Smoking Cessation Standard (SMK-STD)

Active Comparator group

Description:

A contact-equivalent control that provides standard smoking cessation telephone counseling

Treatment:

Behavioral: Smoking Cessation Standard