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Completed

NCT Number: NCT03996902

Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain

The goal of this study is to develop and pilot test a brief intervention to increase motivation to quit and smoking cessation treatment engagement among smokers with chronic pain.

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Key information

Conditions

Chronic Pain Behavior Health Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Smoking Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joseph Ditre

Syracuse, New York, 13210, United States

About this study

Pain and tobacco smoking are both critical national health problems, and there is mounting evidence that smokers in pain may represent an important and large subgroup who experience unique barriers and greater difficulty quitting. Smoking has been identified as a risk factor in the onset and exacerbation of chronic pain, and smokers experience greater levels of pain intensity and disability, relative to non-smokers. Initial evidence indicates that quitting smoking may improve pain outcomes (e.g., lower pain intensity) and supports the notion that smoking cessation may be an essential behavior change for smokers in pain. However, the vast majority of smokers are not yet ready to engage a serious quit attempt, and evidence-based treatments for smoking cessation remain dramatically underutilized. Therefore, the goal of this study is to develop and pilot test a brief intervention that will address smoking in the context of pain in order to increase motivation to quit smoking and engagement of available smoking cessation treatment. Participants will be randomized to either the adapted brief motivational intervention or an intervention consistent with standard clinical practice

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current daily cigarette smoking (at least 10/day)
  • Current moderate-very sever chronic pain with a numerical pain rating of at least 4/10
  • At least 18 years of age

Exclusion criteria

  • Current active attempt to quit smoking
  • Enrollment in smoking cessation treatment or use of a smoking cessation medication
  • Less than 18 years of age

Treatment and study plan

Tailored intervention

Behavioral

Brief motivational smoking intervention tailored to address smoking in the context of pain. Included a novel pain-smoking psycho education component, personalized feedback component, and elicitation of participant's pain-related goals to develop discrepancy between continued smoking and desired pain outcomes.

Ask-Advise-Refer

Behavioral

The Ask-Advise-Refer intervention is commonly used in standard clinical practice.

Primary outcomes

  1. Motivation to Quit Smoking

    Time frame: 30 days

    Measured by the Contemplation Ladder and Motivation Rulers. The contemplation ladder is a measure of motivation to quit smoking on an 11 point Visual Analogue Scale. Motivation rulers for smoking cessation consist of three separate NRSs that asses importance of quitting, readiness to quit smoking in the next month, and confidence that "you will quit smoking" in the next month.

  2. Motivation to engage cessation treatment

    Time frame: 30 days

    Assessed with a single item that asked "would you like to learn about options for treatment to help you quit smoking. If participants answered yes they were then asked whether they were interested and planned to enroll in the following types of treatment in the next 30 days: medication/primary care, Quitline, behavioral health, or none of the above.

  3. Knowledge of pain-smoking interrelations

    Time frame: 30 days

    Using the Pain and Smoking Questionnaire (PSQ) which is a 25 total item questionnaire to asses knowledge of interrelations between pain and tobacco smoking. 17 items assess knowledge of associations between smoking and multiple health conditions. 8 Separate items assess specific knowledge of pain-smoking interrelations such as pain related impairment, whether smoking can cause chronic pain, reduce effectiveness of prescription pain medications, provide analgesic effects, or help to distract from pain.

Secondary outcomes

  1. Smoking behavior

    Time frame: 30 days

    Participants were asked the following questions at the one month follow up: "Do you now smoke cigarettes?" "Over the last week, how many cigarettes did you smoke per day on average?" "In the Past month, have you cut down on your smoking?" "In the past month, did you quit smoking for at least 24 hours?" "In the past month, did you talk to your doctor about your smoking?" "In the past month, did you start using a medication to help you quit smoking? (check all that apply: no, Over the Counter NRT (Patch, gum, lozenge) Prescription NRT (Inhaler, spray) Non-NRT Prescription (Chantix/Zyban))" "In the Past month, did you see a behavioral health provider about your smoking?" "In the past month, did you call Quitline?"

  2. Use of cessation treatment

    Time frame: 30 days

    Participants were asked the following questions at the one month follow up: "Do you now smoke cigarettes?" "Over the last week, how many cigarettes did you smoke per day on average?" "In the Past month, have you cut down on your smoking?" "In the past month, did you quit smoking for at least 24 hours?" "In the past month, did you talk to your doctor about your smoking?" "In the past month, did you start using a medication to help you quit smoking? (check all that apply: no, Over the Counter NRT (Patch, gum, lozenge) Prescription NRT (Inhaler, spray) Non-NRT Prescription (Chantix/Zyban))" "In the Past month, did you see a behavioral health provider about your smoking?" "In the past month, did you call Quitline?"

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2019
Registry last updated
Jun 25, 2019

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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