Pain and Smoking Study

NCT02971137 | Completed Results

• 1 other identifier: IIR 15-092
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 2

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

Conditions

Smoking; Pain; Smoking Cessation

Keywords

Smoking; Cigarette Smoking; Veterans; Tobacco Use; Pain

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)

  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)

  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)

  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)

  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 Outcomes (4)

• Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months

  Baseline to 6-month post intervention

• Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months

  Baseline to 6-month post intervention

• Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months

  Baseline to 12-month post-intervention

• Change in Pain Interference, Difference Between Baseline and Interference

  Baseline to 12-month post intervention

Study Arms (2)

Smoking Cessation plus CBI (SMK-CBI)

EXPERIMENTAL

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

Smoking Cessation Standard (SMK-STD)

ACTIVE COMPARATOR

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

Behavioral: Smoking Cessation Standard

Interventions

Smoking Cessation plus CBI BEHAVIORAL

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

Also known as: SMK-CBI

Smoking Cessation plus CBI (SMK-CBI)

Smoking Cessation Standard BEHAVIORAL

standard telephone-based smoking cessation intervention

Also known as: SMK-STD

Smoking Cessation Standard (SMK-STD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Related Publications (6)

• Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.

  PMID: 28340108 RESULT

• Charokopos A, Card ME, Gunderson C, Steffens C, Bastian LA. The Association of Obstructive Sleep Apnea and Pain Outcomes in Adults: A Systematic Review. Pain Med. 2018 Sep 1;19(suppl_1):S69-S75. doi: 10.1093/pm/pny140.

  PMID: 30203008 RESULT

• Bastian LA, Driscoll M, DeRycke E, Edmond S, Mattocks K, Goulet J, Kerns RD, Lawless M, Quon C, Selander K, Snow J, Casares J, Lee M, Brandt C, Ditre J, Becker W. Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain. Contemp Clin Trials Commun. 2021 Aug 20;23:100839. doi: 10.1016/j.conctc.2021.100839. eCollection 2021 Sep.

  PMID: 34485755 RESULT

• Edmond SN, Snow JL, Pomeranz J, Van Cleve R, Black AC, Compton P, Becker WC. Delphi study to explore a new diagnosis for "ineffective" long-term opioid therapy for chronic pain. Pain. 2023 Apr 1;164(4):870-876. doi: 10.1097/j.pain.0000000000002783. Epub 2022 Sep 15.

  PMID: 36448976 RESULT

• Bastian LA, Driscoll MA, Goulet JL, DeRycke EC, Edmond SN, Mattocks KM, Brandt CA, Kravetz J, Akuley SA, Becker WC. Smoking Cessation Among Patients with Chronic Pain in a Comparative Effectiveness Trial. J Gen Intern Med. 2025 Dec 18. doi: 10.1007/s11606-025-10083-x. Online ahead of print.

  PMID: 41413292 DERIVED

• Muller RD, Driscoll MA, DeRycke EC, Edmond SN, Becker WC, Bastian LA. Factors associated with participation in a walking intervention for veterans who smoke and have chronic pain. J Behav Med. 2024 Dec;47(6):994-1001. doi: 10.1007/s10865-024-00511-4. Epub 2024 Aug 14.

  PMID: 39143444 DERIVED

MeSH Terms

Conditions

Smoking; Pain; Smoking Cessation; Cigarette Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Tobacco Smoking

Limitations and Caveats

Total enrollment was increased from 370 to 371 due to simultaneous enrollment of last subjects for study.

Results Point of Contact

• Title: Dr. Lori A. Bastian
• Organization: VA Connecticut Healthcare System

lori.bastian@va.gov

203-932-5711

Study Officials

• Lori Anne Bastian, MD MPH

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 22, 2016
• Study Start: December 22, 2017
• Primary Completion: October 30, 2021
• Study Completion: January 31, 2022
• Last Updated: July 28, 2023
• Results First Posted: January 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)