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Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain

Primary Purpose

Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychoeducation
Brief smoking control arm
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥18 years
  • chronic pain of greater than 3 months duration
  • smoke at least 10 cigarettes daily

Exclusion Criteria:

  • cancer-related pain
  • current participation in a smoking abstinence program
  • current self-guided attempt to reduce or abstain from smoking
  • use of other forms of tobacco including pipe, cigar or chew
  • history of schizophrenia or other chronic psychotic disorder
  • history of a dementing illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Brief pain and smoking arm

    Brief smoking control arm

    Arm Description

    The experimental arm incorporated a novel psychoeducational component that addressed associations between cigarette smoking and chronic pain

    The brief smoking control arm was comprised of the "5A's" of smoking cessation.

    Outcomes

    Primary Outcome Measures

    Self-report willingness to consider quitting smoking.
    Single question with a binary self-report answer of Yes/No.

    Secondary Outcome Measures

    Thoughts About Abstinence Scale
    The Thoughts About Abstinence Scale is a self-report questionnaire that assesses the desire to quit smoking, anticipated difficulty quitting, and anticipated success quitting smoking.

    Full Information

    First Posted
    July 18, 2018
    Last Updated
    July 31, 2018
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03616743
    Brief Title
    Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain
    Official Title
    Effects of a Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2, 2015 (Actual)
    Primary Completion Date
    October 31, 2016 (Actual)
    Study Completion Date
    October 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A brief smoking cessation intervention was developed to address smoking in the context of chronic pain to increase the intention to engage in smoking cessation treatment.
    Detailed Description
    The primary aim of this randomized controlled trial was to investigate the effects of a brief pain and smoking (BPS) cessation intervention on the willingness to consider quitting smoking in adults with chronic pain seeking treatment in a pain specialty outpatient clinic. The investigators hypothesized that participants randomized to the BPS intervention, relative to a brief non-tailored control smoking (BCS) intervention, would be more likely to self-report willingness to consider quitting smoking. Secondary aims included examining the effects of group allocation on the (1) interest in learning about smoking cessation programs; (2) willingness to consider scheduling a smoking cessation program; (3) scheduling a smoking cessation program; and (4) change scores of the Thoughts About Abstinence Scale (TAAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking Cessation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brief pain and smoking arm
    Arm Type
    Experimental
    Arm Description
    The experimental arm incorporated a novel psychoeducational component that addressed associations between cigarette smoking and chronic pain
    Arm Title
    Brief smoking control arm
    Arm Type
    Active Comparator
    Arm Description
    The brief smoking control arm was comprised of the "5A's" of smoking cessation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducation
    Intervention Description
    Psychoeducation about the links between smoking and chronic pain.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brief smoking control arm
    Intervention Description
    Psychoeducation about the general adverse effects of smoking.
    Primary Outcome Measure Information:
    Title
    Self-report willingness to consider quitting smoking.
    Description
    Single question with a binary self-report answer of Yes/No.
    Time Frame
    Immediate post-intervention assessment
    Secondary Outcome Measure Information:
    Title
    Thoughts About Abstinence Scale
    Description
    The Thoughts About Abstinence Scale is a self-report questionnaire that assesses the desire to quit smoking, anticipated difficulty quitting, and anticipated success quitting smoking.
    Time Frame
    Pre-intervention and immediately post-intervention assessments

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥18 years chronic pain of greater than 3 months duration smoke at least 10 cigarettes daily Exclusion Criteria: cancer-related pain current participation in a smoking abstinence program current self-guided attempt to reduce or abstain from smoking use of other forms of tobacco including pipe, cigar or chew history of schizophrenia or other chronic psychotic disorder history of a dementing illness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William M Hooten, MD
    Organizational Affiliation
    Professor of Anesthesiology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Only a summary of group data will be shared.
    Citations:
    PubMed Identifier
    24333035
    Citation
    Hooten WM, Townsend CO, Hays JT, Ebnet KL, Gauvin TR, Gehin JM, Laures HJ, Patten CA, Warner DO. A cognitive behavioral smoking abstinence intervention for adults with chronic pain: a randomized controlled pilot trial. Addict Behav. 2014 Mar;39(3):593-9. doi: 10.1016/j.addbeh.2013.11.010. Epub 2013 Nov 21.
    Results Reference
    background
    PubMed Identifier
    30641335
    Citation
    Hooten WM, LaRowe LR, Zale EL, Ditre JW, Warner DO. Effects of a brief pain and smoking cessation intervention in adults with chronic pain: A randomized controlled trial. Addict Behav. 2019 May;92:173-179. doi: 10.1016/j.addbeh.2018.11.040. Epub 2018 Nov 28.
    Results Reference
    derived

    Learn more about this trial

    Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain

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