For psychedelics to become widely accessible medicines, they must undergo the clinical trial process to prove safety and efficacy.
Psychedelics are at various stages of this process. Their therapeutic potential is being tested for everything from depression to smoking cessation to eating disorders.
The very best research institutions and companies in the psychedelic space are working together to get these drugs through the clinical process – turning these medicines into viable therapy options for those who need them most.
Here are 5 of the most interesting trials that are currently underway.
1. Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
At Imperial College London, researchers are recruiting participants for a Phase I/II trial assessing the acceptability and efficacy of treating anorexia nervosa (AN) with psilocybin. Twenty participants will receive three doses of psilocybin (max 25mg) with psychological support.
The researchers will also use imaging techniques like MRI and EEG to understand better how psilocybin might treat AN.
2. Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
Psilocybin has already been shown to help people quit smoking in one of the most well-known psychedelics studies.
Matthew Johnson and the team at Johns Hopkins are revisiting this potential use of psilocybin – this time with many more participants.
The researchers are in the process of recruiting 100 participants for the trial. These participants are randomly assigned to receive either psilocybin (n=50) or a nicotine patch (n=50). All participants are undergoing the same preparation protocol. Their smoking status is assessed at three follow up sessions.
3. An Observational Pre-post Study Evaluating the Safety of Tabernanthe Iboga Exposure
At Stanford, Nolan Williams and his team are conducting the world’s first trial using imaging techniques to investigate the effects ibogaine therapy has in a population with a history of head trauma, combat or blast exposure.
Thirty veterans taking part in ibogaine retreats outside of the U.S. are having their brains scanned before and after the retreat and undergoing psychological and cognitive testing.
This research is supported by VETS, a non-profit organisation helping veterans get the treatment they need.
4. Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
Beckley Psytech continues its efforts to understand if 5-MeO-DMT is safe and how it works in an ongoing Phase I study.
The double-blind, randomised, single ascending dose study aims to evaluate the safety and pharmacokinetics of BPL-003, a dry powder intranasal formulation of 5-MeO-DMT developed by the team at Beckley.
At the beginning of April, the company announced that the trial’s first subjects had been dosed with BPL-003.
5. The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
COMPASS Pathways hopes that the therapeutic potential of COMP360 (psilocybin) will extend to PTSD after its success in helping people with treatment-resistant depression.
The company is recruiting 20 participants for a Phase I open-label study that aims to establish the safety and tolerability of COMP360 in people with PTSD.
These are just five of the ongoing studies that have piqued our curiosity here at Blossom. You can find all trials in our free trials database.
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