MindBio Therapeutics Releases Positive Phase 1 Microdosing Clinical Trial Results.

MindBio Therapeutics Releases Positive Phase 1 Microdosing Clinical Trial Results.

We are delighted to reveal top-line data from Phase 1 Clinical Trials Microdosing LSD in 80 healthy participants.?

The positive findings are progressive for this important research using psychedelic medicines to treat mental health conditions.

Uniquely, MindBio's treatment thesis is focused on "microdosing" psychedelic medicines with its first candidate medicine being Lysergic Acid Diethylamide (LSD).

MindBio is developing a microdosing treatment regimen and a set of safety protocols using best-in-class scientific research, machine learning and artificial intelligence models that we hope will help millions of people suffering from mental health conditions.

Background?

Microdosing of psychedelic drugs is a widespread social phenomenon with diverse claimed benefits to mood and cognition. Randomised controlled trials have failed to produce evidence to support these claims but potentially have limited ecological validity due to laboratory-based dosing.

Methods?

In total, 136 participants were screened and 80 randomised into the trial.

Healthy male volunteers were randomised into LSD (n = 40) and placebo (n = 40) groups and received 14 doses of either 10 μg of LSD or inactive placebo every three days for six weeks.?

First doses were given under supervision, with other doses self-administered.?

Results of safety data, blinding, daily questionnaires, expectancy, and pre-and post-intervention psychometrics and cognitive tasks are presented here.?

Results

1102 microdoses (LSD/placebo) were administered in the trial with 100% adherence to regimen and no diversion of substances.

Daily questionnaires showed credible evidence (>99% posterior probability) of increased ratings of “energy”, “wellness”, “creativity”, “happiness” and “connectedness” on dose days relative to non-dose days, which persisted when controlling for pre-intervention expectancy.

Daily VAS scores were collected, showing the mean of every dose day for every participant organized by drug allocation (Group), as well as the means of the following two non-dose days (Post1/Post2).?

Of the 16 VAS scales, 7 had significant interaction effects which survived a Bonferroni corrected alpha level (α = 0.05/16 = 0.0031): ‘angry’, ‘connected’, ‘creative’, ‘energy’, ‘happy’, ‘irritable’, and ‘well’.?

Bayesian modelling showed a very similar pattern of results with the same measures having Bayesian 95% credible intervals which did not overlap 0, excluding ‘angry’.

The analyses showed it was highly probable (>99.9%) that an effect existed for ‘energy’, ‘happy’, ‘well’ and ‘irritable’ and probable (>99%) that it existed for ‘connected’ and ‘creative’.?

There was a likely effect for ‘angry’ and ‘tired’.

Adverse Events (AEs)

Analysis of AE data from all randomised participants (N = 80) shows the proportion of participants who experienced an AE in the LSD group was 85.0% and in the placebo group was 80.0%, the odds ratio (OR) was not statistically significant (OR = 1.4, 95% CI [0.4, 5.5], Fishers exact p = 0.77).?

Median severity for AEs was mild in both the LSD group and the placebo group. There were no deaths, serious or severe AEs in the study.

Proportion tests of the number of participants who experienced an event in each condition showed that only ‘jitteriness’ was statistically significant.?

The proportion of participants who experienced ‘jitteriness’ in the LSD group was 32.5%, and in the placebo group was 7.5%; the odds of reporting ‘jitteriness’ were significantly higher in the LSD group (OR = 5.62, 95% CI [1.6, 27.7], Fisher’s exact p = 0.01). Four participants were withdrawn from the LSD group due to the emergence of mild anxiety.

Summary

  • Home-based microdosing studies are feasible and practical
  • AE profile of LSD microdosing is good (in data collected so far)
  • Jitteriness can emerge in a subset of volunteers
  • Subtle dose titration to optimise treatment regimen will be important for future trials
  • The increases in, “energy”, “well”, “happy”, “creative”, “connected” are suggestive of anti-anhedonic properties that may have potential when used in patients with depression.

Please go here if you'd like a soft copy of the summary and any updates and published papers.

https://sendfox.com/lp/3z847w

David Nichols

Director of Drug Discovery at 2A Biosciences

1 年

Where was this published?

David Galloway

Senior Investment Advisor at Epic Securities

2 年

Hugh very intersting research ..seems from my recollections that Cary Grant ..the movie Star ..many years ago was treated in a small doze process and put his emotional evolvement and mental stability due completely to his LSD regime..,and swore by its curative powers for the rest of his life.In fact he put his success as an actor down to his treatment with LSD. Best wishes Scotty.

Alaina Jaster

Postdoctoral researcher interested in psychedelics, cannabinoids, serotonin, substance use disorders and generational trauma.

2 年

How did you decide on 10 ug? And if 10 ug is your microdose, what is the inactive placebo? Wouldn’t 10ug also be “inactive” ?? also curious about when post1 and post2 were measured? As it seems the scores for the results are only increased during “dose”. excited to see full dataset and publication of these results, as more microdosing studies are needed

Chloe Deutscher

Entrepreneur| Consultant - Driving innovation and spreading awareness in health & biotech

2 年

Huge thank you to the MindBio Therapeutics team for conducting this very important and impactful research! Looking forward to how the research progresses and how many lives this can positively impact. This is just the beginning!

This is very exciting news and I can't wait to hear how the research develops!

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