Open-Label Trial Comparing Oxycodone Medications
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Extended Release Oxycodone; Immediate Release Oxycodone
Intervention description: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours; IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Pain; This clinical trial will compare immediate-release (IR); oxycodone and extended-release (ER) oxycodone in the; management of chronic pain

Summary:

      The investigators hypothesize that subjects will have greater pain relief when taking
      IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying
      amount of medication at six different points over the course of a day will allow patients to
      take as much (or as little) medication as they need to control their pain. In addition, the
      ability to vary the medication doses in this way will give them a greater sense of control,
      which will also contribute to greater pain relief. Similarly, the investigators predict that
      patients will show greater benefits with IR-oxycodone on the measures of physical and
      emotional functioning. Because there is relatively little data on sleep apnea in chronic pain
      patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based.
      Finally, although it is typically thought that the abuse liability of IR-opioid medications
      is greater than for ER-medications, the data on which this belief are based have not involved
      systematic studies of patients with chronic pain; the assessments of abuse liability will
      therefore also be exploratory.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be at least 18 years old.

          2. Be able to read and understand English.

          3. Have a diagnosed chronic pain condition with pain every day or most days for the
             previous 6 months.

          4. Be receiving the equivalent of no more than 40-120 mg daily of an opioid analgesic
             that can be safely converted to oxycodone; this dosage includes all use of opioid
             analgesics, including for "rescue" and for "breakthrough" pain.

          5. Have an average daily pain rating for the baseline week of pain ratings equal to 4.0
             or greater on a 0-10 numerical pain rating scale (NRS) of average pain intensity in
             the past 24 hours.

          6. Have completed at least 6 of the 7 daily diaries during the baseline week.

          7. Have at least 5 baseline week pain diary ratings equal to 3 or greater on the 0-10
             NRS, with no more than one rating of 9 and no ratings of 10.

          8. Have stable concomitant use of all pain-related medications for 8 weeks prior to
             screening and being willing to continue stable use of these medications for the
             duration of the trial.

          9. Have the ability to either independently or with an accompanying person come to the
             research center for study visits.

        Exclusion Criteria:

          1. Treatment of their chronic pain with nerve blocks or any other interventional
             procedure within the past 8 weeks.

          2. A Beck Depression Inventory score < 27 at baseline or clinically significant
             depression or dementia that, in the opinion of the investigator, may interfere with a
             subjects' adherence to the study protocol and/or the accurate and consistent reporting
             of pain.

          3. History of suicide attempt within the past 2 years or current suicide plan or intent.

          4. History of excessive alcohol use or any illicit drug use within the past 2 years.

          5. Lack of adequate birth control in pre-menopausal women of child-bearing age and/or a
             positive urine pregnancy test, which will be performed on all women except those > 2
             years post-menopausal or who have had a hysterectomy).

          6. History of malignancy within the past five years with the exception of successfully
             treated non-metastatic basal cell or squamous cell carcinomas of the skin.