Clinical trial NCT02971137: Pain and Smoking Study
Official title: Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Pain
Smoking Cessation
Keywords: Smoking
Cigarette Smoking
Veterans
Tobacco Use
Pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-11-22
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)
timeFrame: 6-month
measure: Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
timeFrame: 12-month post intervention
measure: Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)
timeFrame: 6-month post intervention
measure: Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)
timeFrame: 12 month post intervention
Secondary outcomes:
measure: Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months
timeFrame: Baseline to 6-month post intervention
measure: Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months
timeFrame: Baseline to 6-month post intervention
measure: Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months
timeFrame: Baseline to 12-month post-intervention
measure: Change in Pain Interference, Difference Between Baseline and Interference
timeFrame: Baseline to 12-month post intervention
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System, Leeds, MA
state: Massachusetts
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Lori Anne Bastian, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.