Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study
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