NCT03616743

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

July 18, 2018

Last Update Submit

July 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-report willingness to consider quitting smoking.

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

    Immediate post-intervention assessment

Secondary Outcomes (1)

  • Thoughts About Abstinence Scale

    Pre-intervention and immediately post-intervention assessments

Study Arms (2)

Brief pain and smoking arm

EXPERIMENTAL

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

Behavioral: Psychoeducation

Brief smoking control arm

ACTIVE COMPARATOR

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

Behavioral: Brief smoking control arm

Interventions

PsychoeducationBEHAVIORAL

Psychoeducation about the links between smoking and chronic pain.

Brief pain and smoking arm

Psychoeducation about the general adverse effects of smoking.

Brief smoking control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 24333035BACKGROUND
  • 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.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • William M Hooten, MD

    Professor of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 6, 2018

Study Start

November 2, 2015

Primary Completion

October 31, 2016

Study Completion

October 31, 2016

Last Updated

August 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Only a summary of group data will be shared.