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
  Purpose

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.


Condition Intervention Phase
Chronic Low Back Pain
Degenerative Disc Disease
Depression
Anxiety
Drug: Oxycodone
Drug: Morphine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 81
Study Start Date: February 2009
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Opioid Medication
Medication all participants receive (oxycodone or morphine)
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01502644

Locations
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Arthritis Foundation
Investigators
Principal Investigator: Ajay D Wasan, MD, MSc Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Assistant Professor of Anesthesiology and Psychiatry, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01502644     History of Changes
Other Study ID Numbers: 2007P-001047, 5K23DA020681-05
Study First Received: December 28, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
low back pain
opioids
mood symptoms

Additional relevant MeSH terms:
Low Back Pain
Depression
Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014