Back to resultsCognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
Primary Purpose
Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral
Control
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking cessation, Nicotine dependence, Chronic pain
Eligibility Criteria
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
Sites / Locations
- Mayo Pain Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive behavioral
Control
Arm Description
Subjects with receive a cognitive behavioral intervention for smoking cessation
Treatment as usual
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
A key secondary outcome measure will be self-report pain severity at 6-months following completion of the experimental intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01091090
Brief Title
Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
Official Title
Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
Smoking cessation, Nicotine dependence, Chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral
Arm Type
Experimental
Arm Description
Subjects with receive a cognitive behavioral intervention for smoking cessation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral
Other Intervention Name(s)
Cognitive, Behavioral, Smoking Cessation
Intervention Description
Cognitive behavioral intervention for smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
A key secondary outcome measure will be self-report pain severity at 6-months following completion of the experimental intervention.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mayo Pain Rehabilitation Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19732372
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.
Results Reference
background
PubMed Identifier
19095867
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.
Results Reference
background
PubMed Identifier
18721171
Citation
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.
Results Reference
background
Learn more about this trial
Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
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