Pain and Smoking Study

Pain Clinical Trial

— PASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971137
• Other study ID #: IIR 15-092
• Status: Completed
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: January 31, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Smoking
• Smoking Cessation

Intervention

Behavioral:
• Smoking Cessation plus CBI
proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
• Smoking Cessation Standard
standard telephone-based smoking cessation intervention

Locations

Country	Name	City	State
United States	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 counse — View 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. — View 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 2 — View 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. Pai — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months	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
Secondary	Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months	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
Secondary	Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months	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
Secondary	Change in Pain Interference, Difference Between Baseline and Interference	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