A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers

Summary & key facts

Researchers gave a new vaporized form of 5-MeO-DMT to 22 healthy volunteers to see how safe it was and how strong the psychedelic effects were at different single doses (2, 6, 12, 18 mg) and when doses were stepped up for each person. Higher single doses produced stronger psychedelic experiences than the lowest dose. Letting each person escalate their dose produced the strongest effects. There were no clear changes in thinking, mood, or general well-being right after the drug, vital signs at 1 and 3 hours were unchanged, and side effects were usually mild and went away on their own. This was a small early safety study in healthy people, so it does not prove the drug helps with conditions like depression, but it helps decide how to test it next in patients.

Key facts:

• The study tested a vaporized 5-MeO-DMT formulation in 22 healthy volunteers. Participants received single doses of 2 mg (4 people), 6 mg (6 people), 12 mg (4 people), 18 mg (4 people), or an individualized dose-escalation plan (4 people).
• Researchers used several questionnaires that measure the strength and quality of psychedelic experiences, including scales for peak or mystical-type experiences, feeling of losing a normal sense of self, challenging experiences, and altered states of consciousness.
• Higher single doses (6, 12, 18 mg) led to stronger psychedelic experience ratings than the lowest 2 mg dose on nearly all questionnaires, except the questionnaire that measures challenging or difficult experiences, which did not increase.
• When people followed an individualized dose-escalation plan, their scores were highest on several measures, including peak experience, mystical-type experience, ego dissolution, and altered states of consciousness.
• Measures of thinking skills, mood, and reported well-being did not show changes after 5-MeO-DMT in this study of healthy volunteers.
• Heart rate, blood pressure, and similar vital signs measured at 1 hour and 3 hours after dosing were not changed, and reported side effects were generally mild and went away without treatment.
• The study was an early phase safety and dosing study in healthy people. It does not show that 5-MeO-DMT helps with depression, but it helps researchers plan how to give doses in future studies with patients.

Abstract

5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT) is a tryptamine with ultra-rapid onset and short duration of psychedelic effects. Prospective studies for other tryptamines have suggested beneficial effects on mental health outcomes. In preparation for a study in patients with depression, the present study GH001-HV-101 aimed to assess the impact of four different dose levels of a novel vaporized 5-MeO-DMT formulation (GH001) administered via inhalation as single doses of 2 (N = 4), 6 (N = 6), 12 (N = 4) and 18 mg (N = 4), and in an individualized dose escalation regimen (N = 4) on the safety, tolerability, and the dose-related psychoactive effects in healthy volunteers (N = 22). The psychedelic experience was assessed with a novel Peak Experience Scale (PES), the Mystical Experience Questionnaire (MEQ), the Ego Dissolution Inventory (EDI), the Challenging Experience Questionnaire (CEQ), and the 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC). Further aims were to assess the impact of 5-MeO-DMT on cognitive functioning, mood, and well-being. Higher doses of 5-MeO-DMT produced significant increments in the intensity of the psychedelic experience ratings as compared to the lowest 2 mg dose on all questionnaires, except the CEQ. Prominent effects were observed following single doses of 6, 12, and 18 mg on PES and MEQ ratings, while maximal effects on PES, MEQ, EDI, and 5D-ASC ratings were observed following individualized dose escalation of 5-MeO-DMT. Measures of cognition, mood, and well-being were not affected by 5-MeO-DMT. Vital signs at 1 and 3 h after administration were not affected and adverse events were generally mild and resolved spontaneously. Individualized dose escalation of 5-MeO-DMT may be preferable over single dose administration for clinical applications that aim to maximize the experience to elicit a strong therapeutic response.

Topics

Chemical synthesis and alkaloids Neurotransmitter Receptor Influence on Behavior Psychedelics and Drug Studies

Categories

Clinical Psychology Psychology Social Sciences

Tags

Adverse effect Hallucinogen Medicine Mood Pharmacology Psilocybin Psychiatry Tolerability Tryptamine Tryptamines

Substances

Psilocybin

Conditions & symptoms

Depression Sadness or low mood