Opioid Dependence Clinical Trial
Official title:
An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals
This study seeks to determine the suitable doses of fentanyl with acceptable adverse effect and safety profile in opioid-dependent patients. The investigators anticipate that a well tolerated dose of fentanyl which produces demonstrable analgesia will be found and will be related to the patient's maintenance opioid dose.
Fentanyl is a synthetic opiate with a (clinical) potency of 50 to 100 times that of
morphine. Because of its high lipid solubility, fentanyl has a rapid onset of action and a
relatively short duration of action. Fentanyl is one of the most widely used agents in the
synthetic opioids family. Being a pure agonist with no active metabolites, it is highly
suitable for use in patients with opioid tolerance. It can be used outside of an
intensive-care clinical environment.
Evidence-based guidelines for clinicians on which agents to use, what doses should be
considered and whether treatment doses are related to the dose and the pharmacological
properties of the maintenance opioid are lacking, but needed. This study seeks to determine
the suitable doses of fentanyl required in opioid-tolerant patients, which are able to
overcome the tolerance and hyperalgesia while maintaining an acceptable therapeutic index.
The importance of this study is that it has the potential to improve acute pain management
in the opioid-tolerant population.
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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