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CompletedNCT03616743Updated Aug 6, 2018

Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain

An interventional study of Psychoeducation and Brief smoking control arm in Smoking Cessation, sponsored by Mayo Clinic. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-06.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Nov 2015, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Smoking Cessation

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In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralPsychoeducation

    Psychoeducation about the links between smoking and chronic pain.

  • BehavioralBrief smoking control arm

    Psychoeducation about the general adverse effects of smoking.

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What researchers measure

Primary outcomes

  1. Self-report willingness to consider quitting smoking.

    Single question with a binary self-report answer of Yes/No.

    Time frame: Immediate post-intervention assessment

Secondary outcomes

  1. 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.

    Time frame: Pre-intervention and immediately post-intervention assessments

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 24333035 ↗
  • 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. PubMed 30641335 ↗

Individual participant data

Plan to share: No — Only a summary of group data will be shared.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03616743
Lead sponsor
Mayo Clinic
Responsible party
W. Michael Hooten (Professor of Anesthesiology, Mayo Clinic) — Principal investigator
First posted
Aug 6, 2018
Start date
Nov 2, 2015
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016
Last update
Aug 6, 2018

Study contacts

William M Hooten, MD
principal investigator · Professor of Anesthesiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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