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Pain and Smoking Study (PASS)

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ClinicalTrials.gov Identifier: NCT02971137
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 22, 2017
Estimated Primary Completion Date : April 2, 2020
Estimated Study Completion Date : November 2, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: SMK-STD




Primary Outcome Measures :
  1. Cigarette Smoking Abstinence Rates [ Time Frame: 6-month ]
    Prolonged smoking abstinence rates

  2. Cigarette Smoking Abstinence Rates [ Time Frame: 12-month post intervention ]
    Prolonged smoking abstinence rates

  3. Cigarette Smoking 7-day Point Prevalence Abstinence Rates [ Time Frame: 6-month post intervention ]
    7-day point prevalence abstinence rates will be measured

  4. Cigarette Smoking 7-day Point Prevalence Abstinence Rates [ Time Frame: 12 month post intervention ]
    7-day point prevalence abstinence rates will be measured


Secondary Outcome Measures :
  1. Change in Pain Intensity [ Time Frame: 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.

  2. Change in Pain Interference [ Time Frame: Baseline to 6-month post intervention ]
    Interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked before and after intervention.

  3. Change in Pain Intensity [ Time Frame: 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.

  4. Change in Pain Interference [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971137


Contacts
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Contact: Lindsey M Russo (203) 932-5711 Lindsey.Russo@va.gov
Contact: Lori A Bastian, MD MPH (203) 932-5711 ext 2655 Lori.Bastian@va.gov

Locations
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United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Lindsey M Russo    (203) 932-5711    Lindsey.Russo@va.gov   
Contact: Lori A Bastian, MD MPH    (203) 932-5711 ext 2655    Lori.Bastian@va.gov   
Principal Investigator: Lori Anne Bastian, MD MPH         
Sub-Investigator: Mary Driscoll, PhD         
Sub-Investigator: Robert D. Kerns, PhD         
Sub-Investigator: Ronald George Hauser, MD         
Sub-Investigator: Sara Edmond, PhD         
Sub-Investigator: William C Becker, MD         
United States, Massachusetts
VA Central Western Massachusetts Healthcare System, Leeds, MA Recruiting
Leeds, Massachusetts, United States, 01053-9764
Contact: Ashley Sherrill, MS    413-584-4040 ext 2098    ashley.sherrill@va.gov   
Contact: Kristin Mattocks, PhD    4135844040 ext 2060    Kristin.Mattocks@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Lori Anne Bastian, MD MPH VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02971137     History of Changes
Other Study ID Numbers: IIR 15-092
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Smoking
Cigarette Smoking
Veterans
Tobacco Use
Pain