Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain

Effects of a Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Psychoeducation; Behavioral: Brief smoking control arm

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report willingness to consider quitting smoking.	Single question with a binary self-report answer of Yes/No.	Immediate post-intervention assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-intervention and immediately post-intervention assessments

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: William M Hooten, MD, Professor of Anesthesiology

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2015
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 14-000475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only a summary of group data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No