Role of Methadone As Co-Opioid Analgesic - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00558870

Purpose

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).

Condition	Intervention	Phase
Pain	Drug: Morphine Drug: Methadone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Role of Methadone As Co-Opioid Analgesic in Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study whether participants taking low-dose methadone plus morphine have a lower pain score and experience fewer side effects as participants taking morphine only. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Morphine Only: Active Comparator	Drug: 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.
Morphine + Methadone: Active Comparator	Drug: 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. Drug: Methadone 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.

Arms

Assigned Interventions

Morphine Only: Active Comparator

Drug: 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.

Morphine + Methadone: Active Comparator

Drug: 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.

Drug: Methadone

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.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individual reporting average pain score for the last 24 hours that is at least a 4 on a numerical scale from 0 to 10 (0= no pain, 10=the worst possible pain) caused by advanced cancer (local recurrence or metastatic disease).
Individual is receiving strong opioids (morphine, fentanyl, oxycodone, hydromorphone) for 3 weeks prior to enrollment.
Individual requires at least 150 mg of daily morphine equivalent daily dose for cancer pain. Using the formula MEDD = dose X MEDD Factor (App L) it would be follows: morphine: a 24 hour total oral intake (sum of PRN and around the clock doses) of 150 mg or greater would qualify the patient, for fentanyl alone: a 24 hour total transdermal intake of 75mcg/h or greater would qualify the patient, for oxycodone alone: a 24 hour total oral intake of 100 mg or greater would qualify the patient, and for hydromorphone alone: a 24 hour total oral intake of 30 mg/day or greater would qualify the patient.
Individual has the ability to receive morphine or methadone orally.
Individual has no known allergy of history of severe toxicity to morphine or methadone.
Individual has normal cognition defined as normal state of arousal and absence of obvious clinical findings of confusion, memory or concentration deficit.
Individual has adequate renal function (creatinine less or equal to 2.0 MG/DL)
Individual has a Zubrod performance status of 3 or lower.
Individual is willing to sign written informed consent.
Individual is 18 years of age or older.
Individual on stable doses(on same dose for at least one week) of nonopioid analgesics including NSAIDS, corticosteroids, gabapentin, pregabalin or antidepressants prescribed for the purposes of pain control.

Exclusion Criteria:

Individual is determined incapable of completing the evaluation forms.
Individual with clinically evident impaired cognition.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558870

Contacts

Contact: Sriram Yennurajalingam, MD

713-792-6085

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sriram Yennurajalingam, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Sriram Yennurajalingam, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Sriram Yennurajalingam, MD/Assistant Professor )
Study ID Numbers:	2006-0641
Study First Received:	November 14, 2007
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00558870 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Solid Tumors
Morphine
Methadone
Co-Opioid Analgesic
Pain

Additional relevant MeSH terms:

Morphine
Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010