The Canadian R&D company Entheon Biomedical has set out to investigate the therapeutic use of the psychedelic dimethyltryptamine (DMT) in treating addiction disorders. Specifically, the company has commissioned a clinical trial investigating the safety and efficacy of using intravenous DMT.

DMT is a hallucinogenic compound and is one of the main active ingredients in ayahuasca, a South American preparation used in shamanistic rituals, and can be extracted from several plants. Its effects are also more transient in contrast to those of other psychedelics, such as LSD and hallucinogenic mushrooms. In addition, DMT has already been shown to be safe to use.

Entheon Biomedical has made an agreement with the Centre for Human Drug Research (CHDR) located in Leiden, Netherlands, to carry out an early phase clinical trial with DMT on humans. According to Entheon’s CEO, Timothy Ko, the main objective of the study is to examine the safety of DMT in humans and, specifically, to evaluate the pharmacodynamics and pharmacokinetics of DMT when administered intravenously. Furthermore, the overarching goal of the clinical study would be to understand DMT’s potential as part of a therapeutic protocol to treat substance use disorders.

“Substance-use disorder is obviously a very complicated situation for both the individual grappling with it and for a society and public health system that is tasked with addressing and remedying the devastating effects and widespread damage that stems from unchecked substance-use disorder,” said Ko said in his interview with Technology Networks. “With no straightforward solution present, our belief is that a medicalized, psychedelic-assisted therapy model provides a powerful tool for substance-use sufferers to gain the clarity and support required to reclaim their lives.”

According to Ko, the fact that DMT is rapidly metabolized makes it well-suited to a shorter, more tailored therapy experience, which also decreases its costs and increases its scalability. Moreover, due to its rapid mode of action, DMT can provide the control necessary, which cannot be achieved with other longer-lasting psychedelics.

The clinical study will focus on target indications of nicotine addiction, alcohol-dependency and opioid use disorder. However, the study will examine whether DMT is effective in the context of mechanisms underlying drug-seeking and using behaviour, which could make it applicable when treating addictions for other drugs. “From this standpoint, our aim is to prove efficacy for the initial target indication and then expand to focus on additional indications and substance-use disorders,” said Ko.

The clinical trial is projected to start at the end of 2021. Despite the logistical challenges presented by the ongoing COVID-19 pandemic, the researchers are trying to make sure that the study stays on schedule. “But really, given the pressing need for effective treatments, paired with the growing loss of life from overdose, and the significant social and economic impact of substance-use disorders, an effective and scientifically validated solution cannot come quickly enough,” said Ko.