According to a recent news release, the first cohort – consisting of healthy volunteers – was dosed in a Phase 1 clinical trial evaluating an intranasal formulation of 5-MeO-DMT. Ultimately, the trial seeks to understand the therapy’s potential safety and whether it is tolerable for patient treatment. The intranasal formulation is designed to treat patients with treatment-averse depression or other neuropsychiatric disorders.
So what exactly is 5-MeO-DMT? According to Drug Science, 5-MeO-DMT is:
a natural psychedelic drug found in the venom of the Colorado River toad, Bufo Alvarius, also known as the Sonoran Desert toad. Smoking 5-MeO-DMT induces a short but intense psychedelic experience or ‘trip’, with hallucinogenic effects that are significantly stronger than those induced by DMT (the primary psychoactive molecule found in Ayahuasca).
In the past, research has suggested that 5-MeO-DMT could be used to treat certain mood disorders, such as bipolar disorder or major depressive disorder (MDD). Within this study, spearheaded by Beckley Psytech, which works to treat conditions using psychedelic medicines, researchers hope to understand how intranasally administered 5-MeO-DMT could benefit patients.
The Phase 1 clinical trial is the first of its kind to evaluate the pharmacokinetic profile of intranasal 5-MeO-DMT, as well as how the treatment is metabolized. Altogether, up to 42 participants will enroll in six separate cohorts. During the trial, cohorts will receive various ascending 5-MeO-DMT doses. Participants have never been previously treated with any sort of psychedelics. In addition to evaluating safety and tolerability, researchers will also be evaluating the types of psychedelic experiences felt by the cohort participants following treatment.
Once a treatment dose is established, this dose will be used in later clinical trials. As treatment-resistant depression is, as the name suggests, difficult to treat, 5-MeO-DMT has the potential to change the treatment field and greatly improve patient outcomes.
According to the clinical trial webpage, researchers hope to evaluate the following outcomes within this study:
- How many participants, after being treated, experience adverse reactions or effects within 65 days (when the follow-up occurs)
- Peak plasma concentration and how long it takes to reach this point
- The area under the plasma concentration time curve