Clinical trial NCT00558870
Conditions: Pain
Keywords: Solid Tumors Morphine Methadone Co-Opioid Analgesic Pain
Sponsor: M.D. Anderson Cancer Center
Start date: 2007-11-01; Completion date: 2015-01-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objectives:

Primary Objective:

To determine whether the addition of low dose methadone to morphine(in the methadone group) has a lower dose escalation index as compared to the morphine alone(in the morphine group) at Day 15 (+/- 3 days)

Secondary Objectives:

To determine whether individuals on the methadone arm have lower pain intensity than the morphine alone arm as demonstrated by a decrease in two points from baseline (+/- 3 days) in their ESAS score at Day 15 (+/- 3 days).

To determine whether the methadone group of experiences fewer opioid induced neurotoxic side effects (including sedation, myoclonus, hallucinations, hyperalgesia and confusion) as compared to the morphine alone group at Day 15 (+/- 3 days).

Detailed description:
The Study Drugs:

Methadone and morphine are both designed to block pain receptors (cells that are sensitive to particular drugs) in your nerves and brain.

Study Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in toss of a coin) to 1 of 2 groups. Participants in Group 1 will stay on morphine only. Participants in Group 2 will receive morphine plus methadone. You will have an equal chance (50/50) of being placed in either of the 2 groups. You, the medical staff, and study researchers will not know which group you have been assigned to. If necessary, your doctor will be able to find out what group you are in the event of an emergency.

Participants in Group 1 will take 2 doses of "slow-release" morphine by mouth every 12 hours, every day for 15 days (plus or minus 3 days). You will also have access to "immediate-release" morphine to be used, as needed, for pain. If you need more than 3 of these immediate-release doses in a 24-hour period, you should call your study doctor.

Participants in Group 2 will take 1 dose of slow-release morphine and 1 dose of methadone by mouth every 12 hours, every day for 15 days (plus or minus 3 days). You will also have access to immediate-release morphine to be used, as needed, for pain. If you need more than 3 of these immediate-release doses in a 24-hour period, you should call your study doctor.

You will complete a questionnaire once daily about symptoms and pain you may be experiencing. It will take about 5 minutes to complete each time.

You will be provided with a drug diary to write down when and how often you take pain medication.

Study Visits:

On Days 8 and 15 (plus or minus 3 days) the following test and procedures will be performed:

* You will complete 3 questionnaires about any side effects you may be having. They will take about 15-20 minutes to complete.
* You will have tests to see how sensitive your skin is.

On Day 15 only (plus or minus 3 days), you will have blood (about 1 teaspoon) drawn to measure kidney function.

Length of Study:

You will be off-study after Day 15 (plus or minus 3 days). You will be taken off study early if the disease gets worse or intolerable side effects occur.

This is an investigational study. Methadone and morphine are both FDA approved and commercially available. Their use together is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Morphine - Arm 1: 2 Doses of "Slow-Release" Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days)."Immediate-release" morphine may be used, if needed, for pain. arm 2: Arm 2: 1 Dose of Slow-Release Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days).)."Immediate-release" morphine may be used, if needed, for pain.

1 Dose of Methadone PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days)
Interventions: intervention 1: Morphine intervention 2: Methadone
Intervention descriptions: intervention 1: Arm 1: 2 Doses of "Slow-Release" Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days)."Immediate-release" morphine may be used, if needed, for pain. intervention 2: 1 Dose of Methadone PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days)

Arm 2: 1 Dose of Slow-Release Morphine PO Every 12 Hours, Every Day for 15 Days (plus or minus 3 days).)."Immediate-release" morphine may be used, if needed, for pain.

Protocol documents: