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NCT01091090 Clinical Trial

Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain

Smoking Cessation Clinical Trial

Official title:
Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01091090
Other study ID # 09-006264
Secondary ID
Status Completed
Phase N/A
First received March 10, 2010
Last updated May 23, 2012
Start date November 2009
Est. completion date September 2011

Study information
Verified date May 2012
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Millions of individuals with chronic pain smoke and our preliminary research suggests that currently available strategies to help people quit smoking may not be effective for individuals with chronic pain. This is important in that smokers with chronic pain have worse pain-related health outcomes compared to nonsmokers with chronic pain. The primary aim of this research project is to develop a smoking cessation intervention for specific use in an outpatient clinical setting for smokers with chronic pain.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Chronic pain

- Age > 18 years

- Cigarette smoker > 10 per day

Exclusion Criteria:

- Concurrent substance use disorder other than nicotine dependence

- Concurrent major psychiatric disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive behavioral
Cognitive behavioral intervention for smoking cessation
• Control
Treatment as usual

Locations
Country Name City State
United States Mayo Pain Rehabilitation Center Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hooten WM, Townsend CO, Bruce BK, Schmidt JE, Kerkvliet JL, Patten CA, Warner DO. Effects of smoking status on immediate treatment outcomes of multidisciplinary pain rehabilitation. Pain Med. 2009 Mar;10(2):347-55. doi: 10.1111/j.1526-4637.2008.00494.x. Epub 2008 Aug 18. — View Citation

Hooten WM, Townsend CO, Bruce BK, Shi Y, Warner DO. Sex differences in characteristics of smokers with chronic pain undergoing multidisciplinary pain rehabilitation. Pain Med. 2009 Nov;10(8):1416-25. doi: 10.1111/j.1526-4637.2009.00702.x. Epub 2009 Sep 1. — View Citation

Hooten WM, Townsend CO, Bruce BK, Warner DO. The effects of smoking status on opioid tapering among patients with chronic pain. Anesth Analg. 2009 Jan;108(1):308-15. doi: 10.1213/ane.0b013e31818c7b99. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The key measurement to be used to assess the effect of the experimental intervention will be the status of cigarette smoking at 6-month follow-up. The smoking status will be determined by assessing the 7-day point prevalence use of cigarettes which is defined as the use of any cigarettes within the preceding 7 days of the follow-up date at 6-months. 6 months No
Secondary A key secondary outcome measure will be self-report pain severity at 6-months following completion of the experimental intervention. 6 month No
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