August 13, 2021

August 11, 2021

The Groundwork & Phases of Clinical Research Trials: How Psychedelic Medicines Will Prove Effective 

Clinical trials may be long and arduous, yet their importance in psychedelic research remains unscathed.

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The last few years have witnessed a revival of psychedelics in research and therapy. Research has found that hallucinogens like ibogaine have therapeutic potential and can help treat conditions like PTSD, addiction, and depression. As these mind-altering drugs become part of mainstream therapy, our goal at MINDCURE is to build systems that advocate for treatment efficacy and safe practice spaces. Nonetheless, hallucinogens have come a long way from medicinal use to recreational and finally therapeutic, and without new clinical trials, these controversial drugs may never garner further investigation or support. 

As groundbreaking clinical trials move through different phases of testing interventions with psychedelics, they not only help overcome any potential risks but also determine the drug’s efficacy and safe usage.  

Defining the Stages of a Clinical Trial

Discovery Phase

In the discovery phase, researchers gather viable research ideas and identify molecules with treatment potential that can translate into a clinical trial. The discovery phase is essentially a stepping stone for determining the course of a clinical trial. Most adequately, the discovery stage is a vetting process, whereby multiple molecules go through rigorous laboratory testing before warranting consideration for future clinical trials. 

Preclinical Studies

Essentially, preclinical studies include lab and animal testing to identify lead candidates and compounds for further investigation. Typically, this step can take up to five years before reaching clinical testing with humans. Even then, an investigational new drug (IND) application needs approval before testing can begin in humans. For instance, the FDA placed an almost two-year-long hold on the MAPS-sponsored MT2 phase 1 study. Moreover, it did not get resolved until a Formal Dispute Resolution Request (FDRR) was filed with the Office of Neuroscience.

Phase 1

Following preclinical studies, Phase 1 of clinical trials concentrates on measuring and establishing safety against any adverse reactions in human subjects. For example, the primary purpose of the MAPS MT2 phase 1 study is to determine the safety and evaluate any psychological effects of MDMA in healthy volunteers (HNV). By administering small doses of the drug in participating HNVs, researchers also identify a safe dosing range. For instance, Drs. Juan Sanchez-Ramos and Deborah Mash administered small doses of ibogaine at different concentration levels in their Phase 1 study to determine physiological and psychological effects in volunteers. 

Phase 2

Almost 70% of potential new treatment drugs enter phase 2 of clinical trials. This stage follows a rigorous testing regimen to establish the safety and efficacy of the potential drug in a patient population. 

MAPS has recently completed its second phase of clinical trials, testing MDMA-assisted psychotherapy as a potential treatment for anxiety associated with a life-threatening illness. The underlying hypothesis focuses on establishing the validity of the previously established dose ranges from a non-patient population. Phase 2 trials can last up to two years and usually involve a small sample size without a placebo group; therefore, it cannot conclude the drug’s efficacy. Despite this, Phase 2 trials provide an essential guide for designing Phase 3 of the clinical trial for conclusions. 

Phase 3

Phase 3, or pivotal trials, are the final steps in establishing the drug’s efficacy and safety, and thus, require at least two successful attempts to gather sufficient supporting evidence. Only 33% of drugs make it to this phase, which requires rigorous testing across a wide population sample for conclusivity. Most of the Phase 3 trials are carried out across multiple research centers internationally. The first Phase 3 Study of MDMA-Assisted Therapy for PTSD by MAPS took place in three countries: Canada, the US, and Israel. Given the large patient population required, these trials often last up to four years. 

FDA Approval

Once the drug passes all three clinical trials successfully, researchers and pharmaceutical companies can submit applications for approval to the Food and Drug Administration (FDA) in the United States. This regulatory body reviews the data and assesses the benefits and risks before approving manufacturing and public distribution. However, FDA approval for psychedelics has always been a tough journey. Therefore, FDA approval for Johnson & Johnson’s ketamine-derived nasal spray for depression is considered a cornerstone in reviving and amping psychedelic research for therapeutic gain. 

Reviving and Supporting Psychedelic Research

As researchers strive to understand the benefits of substances like ibogaine in psychedelic therapy, MINDCURE is determined to establish a regulated supply of synthetic pharmaceutical-grade ibogaine in order to foster research activities and support clinicians. Although the clinical trial process is long for traditional medication, the stigma attached to psychedelics may make it longer. Despite this, renowned research centers like MAPS and MINDCURE are resiliently moving forward to introduce psychedelics into mainstream use.

Written by

Naveen Rashid