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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01502644
First received: December 28, 2011
Last updated: June 14, 2017
Last verified: June 2017
  Purpose
Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect [NA]). The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Masking Description:
During the first 2 weeks of treatment participants took short-acting morphine or oxycodone for 1 week and placebo for 1 week in random order. Participants and investigators were blinded during this period. The remainder of the study was conducted in an open-label design.
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 Average Daily Pain Score [ Time Frame: Baseline and Week 20 ]
    Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure. Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure. A positive change from baseline indicates an improvement.


Enrollment: 81
Actual Study Start Date: February 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Negative Affect (NA)
Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Drug: Oxycodone
Daily dosage up to 120 mg
Drug: Morphine
Daily dosage up to 90 mg immediate release or 180 mg extended release
Other Names:
  • Morphine sulfate (MS) Contin
  • Morphine sulfate instant release (MSIR)
  • Morphine sulfate extended release (MSER)
Drug: Placebo
Placebo-matching oxycodone, placebo-matching morphine
Active Comparator: Moderate NA
Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Drug: Oxycodone
Daily dosage up to 120 mg
Drug: Morphine
Daily dosage up to 90 mg immediate release or 180 mg extended release
Other Names:
  • Morphine sulfate (MS) Contin
  • Morphine sulfate instant release (MSIR)
  • Morphine sulfate extended release (MSER)
Drug: Placebo
Placebo-matching oxycodone, placebo-matching morphine
Active Comparator: High NA
Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Drug: Oxycodone
Daily dosage up to 120 mg
Drug: Morphine
Daily dosage up to 90 mg immediate release or 180 mg extended release
Other Names:
  • Morphine sulfate (MS) Contin
  • Morphine sulfate instant release (MSIR)
  • Morphine sulfate extended release (MSER)
Drug: Placebo
Placebo-matching oxycodone, placebo-matching morphine

Detailed Description:

The level of high, moderate or low NA was determined based on the participant's score on the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0 and 21 for either anxiety or depression. Participants were assigned to high, moderate or low NA groups using the following HADS score criteria:

  • High NA = HADS score ≥9 on each subscale
  • Moderate NA = HADS score ≥6 to ≤8 on each subscale
  • Low NA = HADS score ≤5 on each subscale
  Eligibility

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

Inclusion Criteria:

  • Low Back Pain > 3/10
  • Pain > 1 year
  • Degenerative disc disease as seen on magnetic resonance imaging (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 participants off of any other pain medications, such as nonsteroidal anti-inflammatory drugs (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
National Institute on Drug Abuse (NIDA)
Investigators
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
ClinicalTrials.gov Identifier: NCT01502644     History of Changes
Other Study ID Numbers: 2007P-001047
5K23DA020681-05 ( U.S. NIH Grant/Contract )
Study First Received: December 28, 2011
Results First Received: April 7, 2017
Last Updated: June 14, 2017

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

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

ClinicalTrials.gov processed this record on July 19, 2017