Psychedelic Therapies May Soon Combat Addiction

Substance use disorders (SUDs) pose a significant challenge to individuals and healthcare systems worldwide. Despite existing treatments like 12-step programs, detoxification, and medications such as disulfiram, acamprosate, and buprenorphine, the global death toll from SUD-related causes reached 3.2 million in 2019. The financial burden is also significant, with medical costs in the US alone estimated at $35.3 billion in 2018 for those with employer-sponsored insurance.

Psychedelic drug developers have targeted SUDs as a potential area for therapeutic intervention. There are currently eight psychedelic candidates under development for disorders such as alcohol use disorder (AUD) and opioid use disorder (OUD). These candidates include ketamine, psilocybin, and DMT.

Albert Garcia-Romeu, a professor at Johns Hopkins University School of Medicine, states that data so far suggests psychedelics could be more effective than traditional treatments for SUDs. However, the field still awaits the first FDA approval for a psychedelic used in psychiatric settings, and several challenges remain.

Historically, LSD showed promise for treating SUDs in the 1950s and 1960s but research was halted until the 2000s. Ketamine and ibogaine have also shown potential in treating addiction, and current research is focused mainly on psilocybin. New York-based MindMed is developing an LSD derivative, MM120, for generalized anxiety disorder and other therapeutic areas, including SUDs. Daniel Karlin, MindMed’s Chief Medical Officer, highlights the dual psychiatric and neurobiological mechanisms of LSD.

Toronto-based Awakn Life Sciences is in Phase III trials for AWKN-001, a ketamine-based therapy for severe AUD. Anthony Tennyson, Awakn's CEO, explains that ketamine disrupts memories and provides a different perspective on experiences, which can be particularly effective when paired with cognitive behavioral therapy (CBT).

Berlin and U.S.-based atai Life Sciences is focusing on ibogaine for OUD. Ibogaine has shown benefits in reducing withdrawal symptoms and cravings. Srinivas Rao, atai’s Chief Scientific Officer, notes the compelling data supporting ibogaine’s efficacy, and the company plans to start Phase I/IIa trials for its intravenous ibogaine, IBX-210, later this year.

Psychedelic therapies are not without risks. Garcia-Romeu acknowledges the potential for psychological dependence on substances like psilocybin, although they are generally not addictive in the traditional sense. Rao emphasizes that these therapies are intended for supervised medical settings to mitigate risks.

Ketamine and other psychedelics are often combined with talk therapy. Todd Berrios, a U.S. Army veteran, found relief from alcohol dependency and PTSD through a combination of ibogaine and 5-MeO-DMT, although he cautions that these are not cure-alls and require ongoing effort and therapy.

Despite promising research, psychedelic therapies face significant hurdles. They are still experimental and not legal in many places, including the U.S. The regulatory process for Schedule 1 drugs, which includes psychedelics, involves extensive paperwork. Accessibility is another concern, as these treatments are labor-intensive and likely to be expensive, potentially limiting access to those with means.

The stigma surrounding psychedelics also poses a challenge. Rao notes that the societal perception of psychedelics adds an extra layer of difficulty. Psychedelic therapies would require a shift in treatment paradigms, focusing on intermittent rather than daily therapy.

A potential breakthrough could come if Lykos Therapeutics receives FDA approval for its MDMA capsules to treat PTSD, with a decision expected in August 2024. This could pave the way for broader acceptance and use of psychedelic therapies for various conditions, including SUDs.