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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03616743
Other study ID # 14-000475
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2015
Est. completion date October 31, 2016

Study information

Verified date July 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 31, 2016
Est. primary completion date October 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychoeducation
Psychoeducation about the links between smoking and chronic pain.
Brief smoking control arm
Psychoeducation about the general adverse effects of smoking.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-report willingness to consider quitting smoking. Single question with a binary self-report answer of Yes/No. Immediate post-intervention assessment
Secondary 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
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