Pain and Smoking Study

Not Applicable

Completed

• Conditions: Smoking; Pain; Smoking Cessation
• Interventions: Behavioral: Smoking Cessation plus CBI; Behavioral: Smoking Cessation Standard

• Registration Number: NCT02971137
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-22
• Study Start: 2017-12-22
• Primary Completion: 2021-10-30
• Study Completion: 2022-01-31
• Results First Submitted: 2022-02-07
• Results First Submitted QC: 2022-04-08
• Results First Posted: 2023-01-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoking Cessation plus CBI (SMK-CBI)	Smoking Cessation plus CBI	An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
Smoking Cessation Standard (SMK-STD)	Smoking Cessation Standard	A contact-equivalent control that provides standard smoking cessation telephone counseling

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months	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.
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months	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.
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months	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.
Change in Pain Interference, Difference Between Baseline and Interference	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

Trial Locations

Locations (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

VA Central Western Massachusetts Healthcare System, Leeds, MA; 🇺🇸 Leeds, Massachusetts, United States