Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients

• to develop a model of PK/PD study of breakthrough pain
• to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)
• to demonstrate proof of concept

The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.

• Cancer
• Pain

Inclusion Criteria:

• Pain due to cancer or its treatment; controlled baseline pain;
• episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
• ast 10 minutes or longer, and
• are responsive to short acting oral opioids such as morphine or hydromorphone;
• are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
• are able to fill out the study forms

Exclusion Criteria:

• Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
• prior sensitivity to methadone;
• currently are being administered methadone;
• have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
• new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
• are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely