Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865653
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2021-04-26
Brief Title:
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-02
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:
LSD-Bio
Brief Summary:
Lysergic acid diethylamide LSD is used as recreational substance and as a research substance to study the mind Recreationally LSD is typically used in the form of blotters containing LSD tartrate In research both LSD base LSD alone or LSD salt in the form of LSD tartrate are used The oral bioavailability of LSD is not known and LSD alone and LSD as salt have never been directly compared regarding their equivalence of plasma concentrations and effects Because different forms of LSD are used in research it is important to know their difference or equivalence for correct dosing of LSD The present study will compare equivalent doses of LSD base in ethanol orally LSD tartrate in water administered orally LSD base in an orodispersible film administered orally and LSD tartrate in water administered intravenously as well as a placebo using a double-blind randomized counterballanced cross-over design in healthy participants
Detailed Description:
LSD is widely used for recreational and spiritual purposes Additionally LSD is currently reused in experimental studies with healthy subjects and in studies investigating its effects on patients suffering from anxiety depression addiction personality disorders cluster headache migraine and other pathological conditions
When LSD is used recreationally it is administered mostly in the form of LSD tartrate on filter paper blotter or as a liquid In experimental research over the past years LSD has mostly been used in the form of LSD base which is lipophilic and therefore has typically been administered as a solution in ethanol However some researchers have also use LSD tartrate orally or LSD base intravenously Currently it is not clear how these different forms of LSD compare regarding their bioequivalence and effects
The present study therefore compares four different formulations of LSD and placebo 1 An oral drinking solution of LSD base currently used in many research studies 100 μg LSD in 96 ethanol 2 A solid orodispersible film containing LSD base 100 μg LSD 3 LSD tartrate used in research and recreationally 100 μg LSD equivalent of LSD tartrate in water 4 an intravenous administration of LSD tartrate 100 μg LSD equivalent of LSD tartrate in water and 5 placebo for all formulations quadruple-dummy The primary goals are to document the bioequivalence of LSD base 1 and tartrate 3 and to define the oral bioavailability of LSD using an additional intravenous LSD administration
When LSD is used recreationally it is administered mostly in the form of LSD tartrate on filter paper blotter or as a liquid In experimental research over the past years LSD has mostly been used in the form of LSD base which is lipophilic and therefore has typically been administered as a solution in ethanol However some researchers have also use LSD tartrate orally or LSD base intravenously Currently it is not clear how these different forms of LSD compare regarding their bioequivalence and effects
The present study therefore compares four different formulations of LSD and placebo 1 An oral drinking solution of LSD base currently used in many research studies 100 μg LSD in 96 ethanol 2 A solid orodispersible film containing LSD base 100 μg LSD 3 LSD tartrate used in research and recreationally 100 μg LSD equivalent of LSD tartrate in water 4 an intravenous administration of LSD tartrate 100 μg LSD equivalent of LSD tartrate in water and 5 placebo for all formulations quadruple-dummy The primary goals are to document the bioequivalence of LSD base 1 and tartrate 3 and to define the oral bioavailability of LSD using an additional intravenous LSD administration
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