Formulations of psilocybin and psilocin compounds as serotonin agonists in combination with 3,4 methylenedioxymethamphetamine (MDMA)
The present invention is directed to the use of psilocybin and/or psilocin compounds in combination with 3,4-methylenedioxymethamphetamine (MDMA) or other entactogens, to modulate activity of serotonin receptors, and preferably the 5-HT2A serotonin receptor in humans. In certain preferred embodiment, the co-formulation of psilocybin and/or psilocin compounds in combination with MDMA may result in complex modulation activity of serotonin receptors in a subject in need thereof, and may be uses as a therapeutic treatment for one or more serotonin receptor related diseases or conditions.
1 . A composition for treating a serotonin receptor related disease or condition in a subject in need thereof, comprising a therapeutically effective amount of psilocybin or psilocin and 3,4-methylene-dioxymethamphetamine (MDMA), wherein the psilocybin or psilocin and the MDMA modulate activity of a 5-HT2A serotonin receptor in said subject, wherein said serotonin receptor is activated to approximately the same level as the activation by psilocybin or psilocin without MDMA, and wherein said composition additionally comprises at least one pharmaceutically acceptable carrier.
2 . The composition of 1 , wherein the MDMA alleviates one or more negative side-effects of the psilocybin or psilocin.
3 . The composition of 1 , wherein the ratio of psilocybin or psilocin and MDMA is selected from the group consisting of: 1:1; 4:1; 1:8, 1:1 to 1:8; 1:1 to 4:1, 1:1 to 6:1, and 1:1 to 1:10.
4 . The composition of claim 1 , wherein said serotonin receptor related disease or condition is selected from the group consisting of: schizophrenia, addiction, depression, obsessive compulsive disorder (OCD), cluster headaches, dementia, Alzheimer's disease, paralysis, attention deficit-hyperactivity disorder (ADHD), eating disorders, post-traumatic stress disorder (PTSD), anxiety, and autism.
5 . The composition of claim 1 , wherein the psilocybin or psilocin and the MDMA are administered under controlled time-release conditions.
6 . The composition of claim 1 , wherein the MDMA is provided in a time release condition such that it is present prior to intoxication with the psilocybin or psilocin.
7 . The composition of claim 6 , wherein the MDMA is sustained until post intoxication with the psilocybin or psilocin.
8 . The composition of claim 1 , wherein the dose of the psilocybin or psilocin is in a dosage range of 10 μg to 1 g/kg, or 10 μg to 200 mg/kg body weight of the subject being treated, per day.
9 . The composition of claim 1 , wherein the dose of the MDMA is in a dosage range of 10 μg to 1 g/kg, or 10 μg to 200 mg/kg body weight of the subject being treated, per day.