Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
Condition: Chronic Low Back Pain; Degenerative Disc Disease; Depression; Anxiety
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Intervention: Oxycodone; Morphine; Placebo
Intervention description: Daily dosage up to 120 mg; Daily dosage up to 90 mg immediate release or 180 mg extended release; Placebo-matching oxycodone, placebo-matching morphine
Intervention MeSH terms: Morphine; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (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.
Enrollment: 81.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: low back pain; opioids; mood symptoms

Summary:

      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.
    

Eligibility 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.