Debate over hallucinogens like ecstasy getting reintroduced for psychiatric treatment

Psychedelic substances, including esketamine, psilocybin, and MDMA (methylenedioxymethamphetamine including Ecstasy), are experiencing a resurgence as potential treatments for severe psychiatric disorders. These substances, once sidelined in the 1970s due to regulatory restrictions, are now being reintroduced into medical practice, with esketamine-based antidepressants approved in countries like the US, France and Australia pioneering regulatory approval for MDMA and psilocybin in treating certain conditions.

Psychedelics are being hailed as breakthroughs for severe psychiatric conditions, such as treatment-resistant depression and post-traumatic stress disorder (PTSD), often in conjunction with psychotherapy. However, as an article by The Conversation points out, the idea of using psychedelics therapeutically is not new. In the 1960s and 70s, these substances were studied for their medical potential but were soon abandoned due to political and social pressures. Now, with growing interest in innovative mental health treatments, their potential is being revisited.

Limited Scientific Evidence

Despite regulatory progress, a study led by researchers at the University of Rennes highlights significant shortcomings in the scientific evidence supporting psychedelics for psychiatric use. The analysis raises concerns over weak research designs, exaggerated claims of efficacy, and insufficient evaluation of risks.

One key issue is the challenge of conducting double-blind clinical trials with psychedelics. These substances induce unmistakable effects, such as hallucinations and altered perceptions, making it nearly impossible to mask whether a patient has received the drug or a placebo. This lack of “blindness” introduces biases that can compromise the reliability of trial results.

Accelerated Approvals and Scientific Flaws

Psychedelics are often used as treatments of last resort for patients unresponsive to conventional therapies. Regulatory bodies, therefore, frequently utilize accelerated approval pathways to make these treatments available more quickly. However, these pathways often require less rigorous scientific evidence than standard approval processes, potentially compromising the validity of the approvals.

The study identified several issues with existing research on psychedelics, such as trials typically involving small sample sizes and short durations, limiting their applicability. Articles frequently contained errors, even in titles, and tended to overstate the benefits of psychedelics. Researchers often failed to address the limitations of the double-blind methodology for these substances.

Underestimated Risks

Psychedelics carry substantial risks, including serious side effects. For instance, esketamine, used for treatment-resistant depression, has been associated with dissociation, suicidal thoughts, and urinary disorders from chronic use. Psilocybin and MDMA pose risks of severe cardiovascular side effects, particularly due to their metabolites. The heightened vulnerability of patients undergoing psychedelic-assisted psychotherapy also raises concerns about potential abuse and coercion.

Recommendations for Safer Use

To address these concerns, researchers recommend stricter regulations and improved clinical trial designs. They advocate for health authorities to move away from expedited approval processes and adopt more robust scientific standards. By ensuring thorough evaluation of benefits and risks, the therapeutic potential of psychedelics can be better realized while safeguarding patient safety.

In summary, while psychedelics hold promise for treating severe psychiatric disorders, their therapeutic use requires more stringent oversight, rigorous research, and a cautious approach to mitigate risks. This will help balance their potential benefits against the significant challenges they pose.

By Nazrin Sadigova