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Peri-procedural Smoking Cessation Program in Patients With Chronic 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: NCT04605744
Recruitment Status : Terminated (the investigators were unable to recruit a sufficient number of participants)
First Posted : October 28, 2020
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

Study Description
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Brief Summary:
This single arm study will assess whether smoking cessation counseling offered to chronic pain patients is effective in reducing pain and cigarette use.

Condition or disease Intervention/treatment Phase
Chronic Pain Smoking Behavioral: Smoking cessation counseling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Implementation of a Peri-procedural Smoking Cessation Program in Patients With Chronic Pain Undergoing Interventional Pain Management Procedures
Actual Study Start Date : February 18, 2020
Actual Primary Completion Date : December 6, 2021
Actual Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Behavioral: Smoking cessation counseling

    Patients will be given a briefing on the benefits of smoking cessation in the peri-procedural period around their interventional pain procedure. They will also be provided an informational sheet from the American Society of Anesthesiologists promoting cessation. The sheet will contain the 1-800-QUITNOW national hotline phone number.

    Additional an enrollment folder will provided that contains referral information to Cooper's Tobacco Cessation program. This service, free of charge to Cooper Health patients consists of 5 tobacco cessation counselors who use personalized cessation plans, individual and group counseling cessations, Chantix, and education to promote smoking cessation.


Outcome Measures
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Primary Outcome Measures :
  1. Pain [ Time Frame: 6 months ]
    Visual analogue pain score


Eligibility Criteria
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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:

  • Chronic Pain of 3 months or greater
  • Scheduled for interventional pain procedure

Exclusion Criteria:

  • Cancer related pain
  • Current participation in smoking abstinence program
  • History of schizophrenia or other pyschotic disorder
  • History of dementing illness
  • Pregnant patients
  • Diagnosis of depression or anxiety
Contacts and Locations
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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): NCT04605744


Locations
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United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT04605744    
Other Study ID Numbers: 19-171
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations