Earlier this week we explored the rising trend of psychedelics being researched as an option for treatment resistant mental health conditions. Today, we’ll take a closer look at some of the ongoing clinical research and specific clinical trials taking place in this exciting new field.
A lot of the existing body of clinical research into this field surrounds the impact of LSD treatments on Alcoholism. Notable clinical trials include the early 2000’s work by Smart et al. and Hollister et al., in which significant results were revealed at initial check ups but not at six months on the drinking behavior scale. These early studies revealed the importance of using an active placebo control group in psychedelic studies, so as not to misattribute any special therapeutic effects to the new treatments.
Moving forward to 2019, the FDA approved a controversial Ketamine-derived nasal spray created by Johnson & Johnson as a treatment for depression. Thus began a boom of new trials seeking approval for similar methods to treat other mental health conditions. The trials largely follow the pattern of administering a psychedelic in combination with care from a trained therapist.
More recently, there has been a shift in focus towards the use of psilocybin to treat PTSD and treatment resistant depression. In May of this year, a Canadian biotech company, Cybin, gained approval to trial psilocybin treatment for major depressive disorder. Earlier, the US FDA approved psilocybin use as a breakthrough treatment for depression. Now the Cybin trial has begun Phase II trials to assess Cybin’s sublingual psilocybin formulation versus a 25mg psilocybin capsule.
These trial are arising because many of the researchers and scientists in the field believe that mind-altering drugs, when used in a controlled setting in conjunction with supervised therapy, have the ability to “reset” the brain and free people of habitual thought patterns and deeply entrenched cycles that are associated with depression and addiction.
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In addition to keeping you up to date on all things clinical trials, we also act as a digital CRO with a specific focus on patient recruitment and retention. We believe that patient recruitment and study startup (especially study design and study material) are heavily intertwined. After all, study design can make or break clinical trials, and the patient-perspective should be considered when designing studies to ensure that patient targets are met not only on time, but also on budget.
For Citruslabs, patient recruitment starts with study design and ends with trial completion. We recruit patients through our network of health apps, which enables you to connect with thousands of patients in real time. The best part: these patients are already educated and prepared for the clinical trial process.