Abstract
The research described in this thesis focused on the psychedelic and psychoactive effects of the psychedelic drug Mebufotenin (5-MeO-DMT), as well as its safety and therapeutic efficacy. A prominent feature of 5-MeO-DMT is its ability to elicit a psychedelic state, which has been linked to feelings of profoundness and meaningfulness. This state, sometimes referred to as a mystical or peak experience, has been linked to therapeutic effects in patients with anxiety or depression. Two clinical studies were conducted, in which a vaporized 5-MeO-DMT formulation was first delivered to healthy volunteers and, in the second study, to patients with treatment-resistant depression (TRD), in order to assess safety and efficacy. Results indicated that higher doses, eliciting stronger and more profound effects, were related to better clinical efficacy in reducing depressive symptoms, while still being well tolerated and safe.
External check
Conclusion on Validity: The content is valid as a Proof-of-Concept. The research successfully demonstrates safety and establishes a viable dosing protocol (IDR). However, the efficacy claims (87.5% remission) should be treated as preliminary signals rather than confirmed facts due to the small sample size (N=8 in the key group) and the lack of a placebo control. The results justify moving to large-scale Phase 2b/3 randomized controlled trials but are not yet definitive proof of efficacy.
The research described in this thesis focused on the psychedelic and psychoactive effects of the psychedelic drug Mebufotenin (5-MeO-DMT), as well as its safety and therapeutic efficacy. A prominent feature of 5-MeO-DMT is its ability to elicit a psychedelic state, which has been linked to feelings of profoundness and meaningfulness. This state, sometimes referred to as a mystical or peak experience, has been linked to therapeutic effects in patients with anxiety or depression. Two clinical studies were conducted, in which a vaporized 5-MeO-DMT formulation was first delivered to healthy volunteers and, in the second study, to patients with treatment-resistant depression (TRD), in order to assess safety and efficacy. Results indicated that higher doses, eliciting stronger and more profound effects, were related to better clinical efficacy in reducing depressive symptoms, while still being well tolerated and safe.
External check
Conclusion on Validity: The content is valid as a Proof-of-Concept. The research successfully demonstrates safety and establishes a viable dosing protocol (IDR). However, the efficacy claims (87.5% remission) should be treated as preliminary signals rather than confirmed facts due to the small sample size (N=8 in the key group) and the lack of a placebo control. The results justify moving to large-scale Phase 2b/3 randomized controlled trials but are not yet definitive proof of efficacy.
