PASS: Pain and Smoking Study

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT02971137

Collaborator

(none)

370

Enrollment

Locations

Arms

49.3

Anticipated Duration (Months)

185

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Smoking Pain Smoking Cessation	Behavioral: Smoking Cessation plus CBI Behavioral: Smoking Cessation Standard	N/A

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

370 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans

Actual Study Start Date :

Dec 22, 2017

Actual Primary Completion Date :

Jan 31, 2021

Anticipated Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: Smoking Cessation plus CBI proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain Other Names: SMK-CBI
Active Comparator: Smoking Cessation Standard (SMK-STD) A contact-equivalent control that provides standard smoking cessation telephone counseling	Behavioral: Smoking Cessation Standard standard telephone-based smoking cessation intervention Other Names: SMK-STD

Arm

Intervention/Treatment

Experimental: 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

Behavioral: Smoking Cessation plus CBI

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

Other Names:

SMK-CBI

Active Comparator: Smoking Cessation Standard (SMK-STD)

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

Behavioral: Smoking Cessation Standard

standard telephone-based smoking cessation intervention

Other Names:

SMK-STD

Outcome Measures

Primary Outcome Measures

Cigarette Smoking Abstinence Rates [6-month]
Prolonged smoking abstinence rates
Cigarette Smoking Abstinence Rates [12-month post intervention]
Prolonged smoking abstinence rates
Cigarette Smoking 7-day Point Prevalence Abstinence Rates [6-month post intervention]
7-day point prevalence abstinence rates will be measured
Cigarette Smoking 7-day Point Prevalence Abstinence Rates [12 month post intervention]
7-day point prevalence abstinence rates will be measured

Secondary Outcome Measures

Change in Pain Intensity [Baseline to 6-month post intervention]
Pain intensity is a self-reported numeric rating scale question. Rate current pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention.
Change in Pain Interference [Baseline to 6-month post intervention]
Interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked before and after intervention.
Change in Pain Intensity [Baseline to 12-month post-intervention]
Pain intensity is a self-reported numeric rating scale question. Rate current pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention.
Change in Pain Interference [Baseline to 12-month post intervention]
Interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut	United States	06516
2	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts	United States	01053-9764

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT02971137

Other Study ID Numbers:

IIR 15-092

First Posted:

Nov 22, 2016

Last Update Posted:

May 18, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

Study Results

No Results Posted as of May 18, 2021