Acute Analgesic Effects of DMT on Experimentally Induced Pain in Healthy Participants

This randomised, triple-blind, placebo-controlled crossover trial (n=18) will investigate the acute analgesic (anti-pain) effects of N,N-dimethyltryptamine (DMT) on experimentally induced acute nociceptive pain, hyperalgesia, and allodynia in healthy participants.

N,N-dimethyltryptamine (DMT), a classical psychedelic, has shown promise in treating pain-related conditions, but rigorous clinical trials are lacking. The study aims to evaluate DMT’s efficacy in managing different pain qualities, using a validated electrical stimulation model in healthy volunteers. Participants will receive intravenous infusions of DMT, racemic ketamine (active control), or placebo on separate days in a randomised, counter-balanced order.

The primary outcome measure is the difference in cumulative Numeric Rating Scale (NRS) scores (0 – 10) between DMT, ketamine, and placebo conditions during infusion. Secondary outcome measures include assessing areas of hyperalgesia and allodynia, subjective effect ratings, plasma levels of DMT and ketamine, and their association with personality traits.

This study, sponsored by University Hospital, Basel, Switzerland, is expected to commence in May 2024 and conclude by February 2025. Participants must be aged between 25 and 75 years, proficient in German, willing to adhere to study procedures, and refrain from consuming illicit psychoactive substances during the study period. Exclusion criteria include major medical or psychiatric disorders, hypertension/hypotension, recent hallucinogenic/dissociative substance use, pregnancy, and participation in other clinical trials.

Trial Details

N,N-dimethyltryptamine (DMT) is a classical psychedelic with similar effects like LSD or psilocybin. Preliminary evidence from case series and small open-label trials suggests that psychedelics may be promising candidates for the treatment of several pain-related diseases such as chronic pain, migraine, cluster headache or phantom limb pain. However, data from rigorously conducted and randomized clinical trials are lacking. Additionally, the potential acute analgesic properties of psychedelics remain poorly characterized. Therefore, the investigators will evaluate the efficacy of DMT on different pain qualities within a model of electrically induced pain in healthy participants. The analgesic effects will be compared to racemic ketamine (active control) and placebo within a cross-over design.

NCT Number NCT06180759

Data attribution

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