Adverse Effects After Ayahuasca Administration in the Clinical Setting

Abstract

and consult an ophthalmologist immediately. Also, according to the literature, drug-associated acute ACG is believed to be idiosyncratic in nature. That is to say that the ocular adverse effects, unlike the systemic ones, are not dose related, 6 as illustrated in this case report-our patient received only 100 mg of topiramate per day, whereas the recommended clinical dose for approved indications is 200 to 400 mg daily. Supporting its idiosyncratic nature, 3 different reasons can be pointed out: (1) a very small proportion of the patients who are under topiramate treatment develop drug-associated bilateral ACG; (2) low or even subtherapeutic levels of the drug can be associated with the condition;(3) there are cases of topiramate overdose that did not result in bilateral ACG development. 7 Delaying the presentation or continuing the drug can lead to permanent blindness or compromise the quality of vision for life.

Interactive Effects of Ayahuasca and Cannabidiol in Social Cognition in Healthy Volunteers

“…The most significant negative experience in the study was a transient dysphoric episode that included agitation, confusion, anxiety, dissociation/derealization, and visual changes (in the placebo-ayahuasca group). The full report on this case and how it was managed can be found in a previous publication under “Case 2.” 49 …”

“…Brain-derived neurotrophic factor plasma levels were measured as a biological proxy of increased neuroplasticity. 49 Plasma levels of total BDNF were measured by enzyme-linked immunosorbent assay according to the manufacturer's instructions (catalog number DBNT00; Total BDNF Quantikine ELISA Kit, R&D Systems). We used the same quantification method as in our previous trial with healthy volunteers.…”

“…The full report on this case and how it was managed can be found in a previous publication under "Case 2." 49 Two volunteers reported adverse effects after the experimental session. Approximately 5 hours after the experiment (around 6 PM), a volunteer from the CBD-ayahuasca group (already at home) reported a headache on the telephone follow-up.…”

Molecular Pathways of the Therapeutic Effects of Ayahuasca, a Botanical Psychedelic and Potential Rapid-Acting Antidepressant

“…Regarding the occurrence of more significant adverse events in clinical trials with ayahuasca performed by our group, there is a detailed report of the two instances where these effects had to be managed by our research team, how the situation was resolved, and an initial nine step guideline on managing this kind of occurrence [ 76 ]. Overall, it seems that as with other psychedelic administration, a cautious and detailed selection of the volunteers who are allowed to participate in the trials and a supportive setting constructed by researchers has been demonstrated to be enough to reduce and manage the occurrence of AEs in clinical trials.…”

“…Furthermore, with the current published data it is very challenging to determine the optimal DMT to β-carboline ratio and dosages that maximize the therapeutic effects while also minimizing the occurrence of AEs. This and other challenges associated with standardized ayahuasca medicinal use (and other psychedelics) go beyond the main focus of this article and have been thoroughly discussed elsewhere [ 74 , 75 , 76 , 87 ] .…”