A formal feasibility study of sublingual methadone for breakthrough cancer pain

We conducted a feasibility study of sublingual methadone for breakthrough cancer pain, to determine whether a larger, randomized trial was warranted, and to identify a study design that would be likely to succeed. From approximately 1930 patients in the initial pool, nine patients were enrolled. Fiv...

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Bibliographic Details
Published in:Palliative medicine 2010-10, Vol.24 (7), p.696-706
Main Authors: Hagen, Neil A, Moulin, Dwight E, Brasher, Penny MA, Biondo, Patricia D, Eliasziw, Misha, Watanabe, Sharon M, Stiles, Carla R
Format: Article
Language:English
Subjects:
Administration, Sublingual
Adult
Aged
Aged, 80 and over
Alberta
Analgesics
Analgesics, Opioid - administration & dosage
Analgesics, Opioid - pharmacokinetics
Breakthrough pain
Cancer
Clinical trials
Data collection
Dosage
Drug dosages
Drug Monitoring
Feasibility
Feasibility Studies
Female
Health services
Humans
Male
Methadone
Methadone - administration & dosage
Methadone - pharmacokinetics
Middle Aged
Narcotics
Neoplasms - complications
Oncology
Ontario
Pain
Pain - drug therapy
Pain Measurement - drug effects
Palliative care
Patients
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Summary:We conducted a feasibility study of sublingual methadone for breakthrough cancer pain, to determine whether a larger, randomized trial was warranted, and to identify a study design that would be likely to succeed. From approximately 1930 patients in the initial pool, nine patients were enrolled. Five patients completed the study, generating data on 83 discrete episodes of breakthrough cancer pain at optimal dose. Mean pain intensity dropped by 1.7 points (on a 10 point numerical scale) within 10 min of sublingual methadone administration, and by 3.2 points after 15 min. No serious or severe toxicity was encountered. Based on the results of this feasibility study, a larger randomized clinical trial of sublingual methadone for breakthrough cancer pain using this trial model would not be successful. Extensive information obtained from small numbers of carefully studied patients provides proof of concept that sublingual methadone is effective, safe, and well tolerated.
ISSN:0269-2163
1477-030X
DOI:10.1177/0269216310375999