Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

This study has been completed.
Sponsor:
Collaborators:
Arthritis Foundation
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01502644
First received: December 28, 2011
Last updated: February 25, 2013
Last verified: February 2013

December 28, 2011
February 25, 2013
February 2009
January 2013   (final data collection date for primary outcome measure)
Percent Change in Pain Score [ Time Frame: Daily for 24 weeks. ] [ Designated as safety issue: No ]
Subjects make daily rating from 0-10 on their low back pain. The percent change in pain score from baseline (week 1 average) is calculated using weekly averages for 24 weeks.
Same as current
Complete list of historical versions of study NCT01502644 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

The purpose of this study is to measure pain relief from chronic low back pain through the use of opioid medications (oxycodone and morphine) and the effect of mood symptoms.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Low Back Pain
  • Degenerative Disc Disease
  • Depression
  • Anxiety
  • Drug: Oxycodone
    up to 120mg daily dosage
  • Drug: Morphine
    daily dosage up to 90mg immediate release and 180mg extended release.
    Other Names:
    • MSContin
    • MSIR
    • MSER
Experimental: Opioid Medication
Medication all participants receive (oxycodone or morphine)
Interventions:
  • Drug: Oxycodone
  • Drug: Morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
Not Provided
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Low Back Pain > 3/10
  • Pain > 1 year
  • Degenerative disc disease as seen on MRI, which must meet minimum disc grading criteria: at least a grade III disc degeneration, a hyperintense zone, or abnormal disc morphology.
  • Patients who may have had back surgery will be included.
  • No epidural steroids or other nerve blocks for back pain either two weeks before or during the study period.
  • No opioids or on short-acting opioids only (max. daily amount=120 mg morphine equivalents). It is not feasible to recruit only opioid naive patients.
  • Must agree to 2-week washout for those on opioids.
  • No active substance abuse.
  • No intention to take new pain or psychiatric treatments during the study, including chiropractic, physical therapy, or complementary or alternative treatments (CAM). It is not feasible to take subjects off of any other pain medications, such as NSAIDS.
  • No pregnancy or the intent to become pregnant during the study, and no nursing mothers.
  • Women, who are able to bear children, must agree to use contraceptives throughout the study.
  • In men, normal baseline testosterone levels.

Exclusion Criteria:

  • Patients with pain due to disorders not including a component of disc degeneration, or those with unknown causes of pain will be excluded.
  • Patients with the intent to undergo back surgery will be excluded.
  • Patients with a history of recent or ongoing alcohol or other drug addiction disorders will be excluded.
  • Patients with any history of substance abuse of opioids will be excluded.
  • Patients whose diagnosis cannot be firmly established according to criteria described above would not be included.
  • Patients whose medical and psychiatric comorbidities are not well controlled, or who are currently experiencing an acute exacerbation of the medical comorbidity, will be excluded.
  • Males with abnormal testosterone levels will be excluded (normal range is 1800-6650 pg/ml).
  • Female patients who nursing will be excluded.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01502644
2007P-001047, 5K23DA020681-05
Yes
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
Brigham and Women's Hospital
  • Arthritis Foundation
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Ajay D Wasan, MD, MSc Brigham and Women's Hospital
Brigham and Women's Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP