Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01091090
First received: March 10, 2010
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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 Intervention
Smoking Cessation
Behavioral: Cognitive behavioral
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091090

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

Additional Information:
Publications:
Responsible Party: W. Michael Hooten, MD, Mayo Clinic Foundation
ClinicalTrials.gov Identifier: NCT01091090     History of Changes
Other Study ID Numbers: 09-006264
Study First Received: March 10, 2010
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Smoking cessation
Nicotine dependence
Chronic pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014