Pain and Smoking Study (PASS)

July 19, 2023 updated by: VA Office of Research and Development

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

371

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Massachusetts
      • Leeds, Massachusetts, United States, 01053-9764
        • VA Central Western Massachusetts Healthcare System, Leeds, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)
Time Frame: 6-month
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
6-month
Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
Time Frame: 12-month post intervention
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
12-month post intervention
Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)
Time Frame: 6-month post intervention
30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?
6-month post intervention
Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)
Time Frame: 12 month post intervention
30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?
12 month post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months
Time Frame: Baseline to 6-month post intervention
BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.
Baseline to 6-month post intervention
Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months
Time Frame: Baseline to 6-month post intervention
Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased.
Baseline to 6-month post intervention
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months
Time Frame: Baseline to 12-month post-intervention
BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.
Baseline to 12-month post-intervention
Change in Pain Interference, Difference Between Baseline and Interference
Time Frame: Baseline to 12-month post intervention
Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased
Baseline to 12-month post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Lori Anne Bastian, MD MPH, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimated)

November 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIR 15-092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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