Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
1 other identifier
interventional
26
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 10, 2010
CompletedFirst Posted
Study publicly available on registry
March 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMay 25, 2012
May 1, 2012
1.8 years
March 10, 2010
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
A key secondary outcome measure will be self-report pain severity at 6-months following completion of the experimental intervention.
6 month
Study Arms (2)
Cognitive behavioral
EXPERIMENTALSubjects with receive a cognitive behavioral intervention for smoking cessation
Control
ACTIVE COMPARATORTreatment as usual
Interventions
Cognitive behavioral intervention for smoking cessation
Eligibility Criteria
You may qualify if:
- Chronic pain
- Age \> 18 years
- Cigarette smoker \> 10 per day
You may not qualify if:
- Concurrent substance use disorder other than nicotine dependence
- Concurrent major psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Pain Rehabilitation Center
Rochester, Minnesota, 55905, United States
Related Publications (3)
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.
PMID: 19732372BACKGROUNDHooten 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.
PMID: 19095867BACKGROUNDHooten 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.
PMID: 18721171BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2010
First Posted
March 23, 2010
Study Start
November 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
May 25, 2012
Record last verified: 2012-05