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Completed

NCT Number: NCT02971137

Pain and Smoking Study

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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Key information

Conditions

Smoking Behavior Cigarette Smoking Health Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Smoking Cessation Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoking Cessation plus CBI

Behavioral

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

Other names: SMK-CBI

Smoking Cessation Standard

Behavioral

standard telephone-based smoking cessation intervention

Other names: SMK-STD

Primary outcomes

  1. Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)

    Time frame: 6-month

    In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?

  2. Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)

    Time frame: 12-month post intervention

    In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?

  3. Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)

    Time frame: 6-month post intervention

    30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?

  4. Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)

    Time frame: 12 month post intervention

    30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?

Secondary outcomes

  1. Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months

    Time frame: 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.

  2. Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months

    Time frame: 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.

  3. Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months

    Time frame: 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.

  4. Change in Pain Interference, Difference Between Baseline and Interference

    Time frame: 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: PASS

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Nov 22, 2016
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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