Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing
Status:
Not yet recruiting
Trial end date:
2023-12-03
Target enrollment:
Participant gender:
Summary
Opioids are commonly prescribed for moderate to severe pain. While initially intended for
moderate to severe acute and cancer pain, opioids are currently frequently considered and
prescribed in chronic noncancer pain. Due to the large increase in opioid prescription rate,
the number of unintentional drug overdoses is rapidly increasing, not only in the Unites
States but also in the Netherlands. A potential lethal consequence of an opioid overdose is
opioid-induced respiratory depression. Additionally, it is well known that opioids are often
used (and abused) in combination with other legal or illicit substances, for example alcohol,
benzodiazepines, cannabis, neuropathic pain medication including the anticonvulsant
pregabaline. There are no high-quality data on the interaction between oxycodone and
(neuropathic pain) medication on the ventilatory control system. Case reports and randomized
studies show that pregabalin induces respiratory depression when combined with opioids. Some
alternatives to pregabalin may have a better safety profile. One such alternative is
lacosamide, an antiepileptic with a different mode of action than pregabalin, and effective
in the treatment of neuropathic pain. We hypothesize that in contrast to lacosamide,
pregabalin will increase the respiratory depressant effect of low-dose oxycodone.
The objective of the study is to quantify the effect of pregabalin and lacosamide on
oxycodone-induced respiratory depression.
24 participants will be screened beforehand if subjects meet the inclusion and exclusion
criteria. If so, the subjects will visit the hospital twice. On both occasions, participants
will take a 10 mg oxycodone tablet and 90 minutes after a capsule of pregabalin or
lacosamide. The order of visits will be randomized. During the visits, at set time points the
hypercapnic ventilatory response will be measured, relief of nociception, pupil diameter and
several side effects other than respiratory depression. There will be a washout period of 7
days between study visits with the study ending after 2 visits.