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Trial record 75 of 2034 for:    Smoking Cessation

Brief Pain and Smoking Cessation Intervention in Adults 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. Identifier: NCT03616743
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Information provided by (Responsible Party):
W. Michael Hooten, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Psychoeducation Behavioral: Brief smoking control arm Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain: A Randomized Controlled Trial
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Brief pain and smoking arm
The experimental arm incorporated a novel psychoeducational component that addressed associations between cigarette smoking and chronic pain
Behavioral: Psychoeducation
Psychoeducation about the links between smoking and chronic pain.

Active Comparator: Brief smoking control arm
The brief smoking control arm was comprised of the "5A's" of smoking cessation.
Behavioral: Brief smoking control arm
Psychoeducation about the general adverse effects of smoking.

Primary Outcome Measures :
  1. Self-report willingness to consider quitting smoking. [ Time Frame: Immediate post-intervention assessment ]
    Single question with a binary self-report answer of Yes/No.

Secondary Outcome Measures :
  1. Thoughts About Abstinence Scale [ Time Frame: Pre-intervention and immediately post-intervention assessments ]
    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.

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

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

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 identifier (NCT number): NCT03616743

Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: William M Hooten, MD Professor of Anesthesiology

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Responsible Party: W. Michael Hooten, Professor of Anesthesiology, Mayo Clinic Identifier: NCT03616743     History of Changes
Other Study ID Numbers: 14-000475
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only a summary of group data will be shared.

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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
Neurologic Manifestations
Signs and Symptoms