Pain and Smoking Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2022-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Smoking Pain Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Smoking Cessation plus CBI

Intervention Type BEHAVIORAL

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

Smoking Cessation Standard (SMK-STD)

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

Group Type ACTIVE_COMPARATOR

Smoking Cessation Standard

Intervention Type BEHAVIORAL

standard telephone-based smoking cessation intervention

Interventions

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Smoking Cessation plus CBI

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

Intervention Type BEHAVIORAL

Smoking Cessation Standard

standard telephone-based smoking cessation intervention

Intervention Type BEHAVIORAL

Other Intervention Names

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SMK-CBI SMK-STD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No