Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-11-20
Brief Title:
Acute Analgesic Effects of DMT on Experimentally Induced Pain in Healthy Participants
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Acute Analgesic Effects of DMT on Experimentally Induced Acute Nociceptive Pain Hyperalgesia and Allodynia in Healthy Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPS
Brief Summary:
NN-dimethyltryptamine DMT is a classical psychedelic with similar effects like LSD or psilocybin Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain migraine cluster headache or phantom limb pain However data from rigorously conducted and randomized clinical trials are lacking Additionally the potential acute analgesic properties of psychedelics remain poorly characterized Therefore the investigators will evaluate the efficacy of DMT on different pain qualities within a model of electrically induced pain in healthy participants The analgesic effects will be compared to racemic ketamine active control and placebo within a cross-over design
Detailed Description:
Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain migraine cluster headache or phantom limb pain However data from rigorously conducted and randomized clinical trials are lacking Additionally the potential acute analgesic properties of psychedelics remain poorly characterized For instance it is unclear whether psychedelics possess acute antinociceptive effects or if they rather modulate secondary pain phenomena such as hyperalgesia allodynia andor functional pain Here the investigators will employ a validated electrical stimulation model in healthy volunteers that produces acute nociceptive pain but also features of chronic pain such as hyperalgesia and allodynia The model is established for the detailed assessment of the analgesic effect of known analgesics or new compounds Thus the investigators will evaluate the efficacy of NN-dimethyltryptamine DMT a classical and naturally-occurring psychedelic on different pain qualities within this model DMT differs from other classical psychedelics in its very short elimination half-life Due to its rapid metabolization by monoaminoxidases MAO DMT is not orally bioavailable in the absence of MAO-inhibitors and thus has to be administered continuously and intravenously Recently the investigators tested several continuous intravenous administration regimes of DMT that lead to the induction of a constant and rapidly adaptable psychedelic state The regime allows to induce stable DMT effect that can be terminated rapidly Due to this controllability a continuous infusion of intravenous DMT is most suitable to assess time and concentration-dependent analgesic effects within the used pain model The analgesic efficacy of DMT will be compared to ketamine a known analgesic positive control and placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None