Pain and Smoking Study

VA Office of Research and Development371 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

371

Conditions

Smoking Pain Smoking Cessation

Interventions

Smoking Cessation plus CBIBEHAVIORAL

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

Smoking Cessation StandardBEHAVIORAL

standard telephone-based smoking cessation intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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?

Time frame: 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?

Time frame: 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?

Time frame: 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?

Time frame: 12 month post intervention

Secondary Outcomes

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.

Time frame: Baseline to 6-month post intervention

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.

Data from ClinicalTrials.gov

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