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Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain

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ClinicalTrials.gov Identifier: NCT01091090
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : May 25, 2012
Sponsor:
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Cognitive behavioral Behavioral: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
Study Start Date : November 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cognitive behavioral
Subjects with receive a cognitive behavioral intervention for smoking cessation
Behavioral: Cognitive behavioral
Cognitive behavioral intervention for smoking cessation
Other Names:
  • Cognitive
  • Behavioral
  • Smoking Cessation
Active Comparator: Control
Treatment as usual
Behavioral: Control
Treatment as usual



Primary Outcome Measures :
  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. [ Time Frame: 6 months ]
    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 :
  1. A key secondary outcome measure will be self-report pain severity at 6-months following completion of the experimental intervention. [ Time Frame: 6 month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091090


Locations
United States, Minnesota
Mayo Pain Rehabilitation Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic