NCT01091090

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

March 10, 2010

Last Update Submit

May 23, 2012

Conditions

Keywords

Smoking cessationNicotine dependenceChronic pain

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

EXPERIMENTAL

Subjects with receive a cognitive behavioral intervention for smoking cessation

Behavioral: Cognitive behavioral

Control

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Control

Interventions

Cognitive behavioral intervention for smoking cessation

Also known as: Cognitive, Behavioral, Smoking Cessation
Cognitive behavioral
ControlBEHAVIORAL

Treatment as usual

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Mayo Pain Rehabilitation Center

Rochester, Minnesota, 55905, United States

Location

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: 19732372BACKGROUND
  • 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.

    PMID: 19095867BACKGROUND
  • 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.

    PMID: 18721171BACKGROUND

Related Links

MeSH Terms

Conditions

Smoking CessationTobacco Use DisorderChronic Pain

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations