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Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996902
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Syracuse University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Smoking Smoking Cessation Behavioral: Tailored intervention Behavioral: Ask-Advise-Refer Not Applicable

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain
Actual Study Start Date : May 10, 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tailored intervention
Brief Motivational Smoking Intervention
Behavioral: Tailored intervention
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.

Experimental: Control
Intervention consistent with standard clinical practice (Control)
Behavioral: Ask-Advise-Refer
The Ask-Advise-Refer intervention is commonly used in standard clinical practice.




Primary Outcome Measures :
  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 Outcome Measures :
  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?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996902


Locations
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United States, New York
Joseph Ditre
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Syracuse University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Emily Zale, PhD Syracuse University
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Responsible Party: Syracuse University
ClinicalTrials.gov Identifier: NCT03996902    
Other Study ID Numbers: SyracuseU
F31DA039628 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Syracuse University:
Chronic Pain
Tobacco
Smoking
Smoking cessation
Motivation
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms