Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects

Exclusion Criteria

• •Psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion
• •A history of alcohol abuse or any illicit drug use within 2 years prior to Screening
• •A positive urine test for illicit drugs at Screening (Exception: If subject has a physician's prescription for an illicit drug; for example, medical marijuana)
• •Known diagnosis of moderate to severe sleep apnea.
• •Prescribed Continuous Positive Airway Pressure (CPAP), Adaptive Servo-Ventilation (ASV) therapy or an oral appliance prescribed for the treatment of moderate to severe sleep apnea (current or previous history)
• •An active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
• •An implanted electrical stimulation device(s) or if the subject is expected to require one of these during the course of the study
• •Planned to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening
• •Prior to Randomization, a subject will be excluded if:
• •Diary does not meet compliance
• •Mean diary-reported 12-hour NPRS \< 6 (on 0 to 10 scale, as reported over 5 days)
• •Positive urine test for alcohol at Baseline
• •Negative urine test for opioids at Baseline
• •Baseline sleep study (PSG) with SaO2 \<=80% for \>= 5 consecutive minutes, and/or an Apnea-Hypopnea Index (AHI) \>=15.