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

This study has been completed.
Arthritis Foundation
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital Identifier:
First received: December 28, 2011
Last updated: February 25, 2013
Last verified: February 2013
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
Drug: Oxycodone
Drug: Morphine
Phase 4

Study Type: Interventional
Study Design: 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 Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital:

Primary Outcome Measures:
  • Percent Change in Pain Score [ Time Frame: Daily for 24 weeks. ]
    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


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01502644

United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
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
  More Information

Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Assistant Professor of Anesthesiology and Psychiatry, Brigham and Women's Hospital Identifier: NCT01502644     History of Changes
Other Study ID Numbers: 2007P-001047
5K23DA020681-05 ( US NIH Grant/Contract Award Number )
Study First Received: December 28, 2011
Last Updated: February 25, 2013

Keywords provided by Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital:
low back pain
mood symptoms

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017