The article What is LSD? A Look at LSD Clinical Trials was originally published on Microdose.
To celebrate Bicycle Day, Microdose is devoting the month of April to an exploration of LSD. To help answer the question of what is LSD? we’re taking a closer look at some of the most important clinical work exploring the therapeutic potential of LSD.
Here’s a list of some major clinical trials using LSD.
MindMed’s Phase 2 Trial Evaluating LSD in Anxiety Disorders
Run by MindMed collaborators Prof. Matthias Liechti and others at University Hospital Basel (UHB), this Phase 2 clinical trial tests the efficacy of LSD in patients with anxiety, with a double-blind, placebo-controlled random-order cross-over trial using two doses of LSD (200 µg) and two placebo sessions.
MindMed and its collaborators announced positive results, with topline data demonstrated significant, rapid, durable, and beneficial effects of LSD to safely mitigate symptoms of anxiety and depression.
The trial has moved onto Phase 2b and begun patient dosing.
LSD-assisted Psychotherapy in Persons Suffering From Anxiety
Back in 2008, MAPS sponsored the first study of the therapeutic use of LSD in humans in over 40 years. It investigated the safety and effectiveness of LSD-assisted therapy in participants with anxiety around their life-threatening illnesses.
According to MAPS: the trial was a double-blind, randomized, active placebo-controlled pilot study in 12 participants included drug-free therapy sessions supplemented by two LSD-assisted therapy sessions scheduled 2 to 3 weeks apart. The participants received either 200 micrograms of LSD (n = 8) or 20 micrograms of LSD with an open-label crossover to 200 micrograms of LSD. Two months after treatment, participants showed a reduction in anxiety (p=0.021) with no acute or chronic adverse events persisting beyond 1 day after treatment and no treatment-related serious adverse events. Follow up data at 12 months showed that anxiety reductions continued to last. These results indicate that when administered in a therapeutic setting, LSD-assisted therapy is associated with lasting reductions in anxiety without safety concerns.
Lysergic Acid Diethylamide (LSD) for Cluster Headaches (LCH)
Another trial being run by the team at University Hospital, Basel, Switzerland, this trial examines the efficacy of LSD for cluster or suicide headaches.
LSD has been reported to abort attacks, to decrease frequency and intensity of attacks, and to induce remission in patients suffering from cluster headaches (CH).
This trial investigate the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three weeks) in patients suffering from CH compared with placebo.
The trial is ongoing. MindMed also owns the rights to results from this trial.
MindBio Therapeutics LSD Microdosing trial
In May 2022, MindBio Therapeutics announced the completion of its 12 month Phase 1 clinical trial microdosing LSD in 80 healthy participants. MindBio is developing a microdosing regimen using LSD to treat mental health disorders such as depression.
At 2022’s Wonderland conference, MindBio presented more data from its trial.
- 1102 microdses (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.
- 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 a very similar 80.0%. There were no deaths, serious or severe AEs in the study.
- Home-based microdosing studies have proven to be feasible and practical.
The company is now moving forward with protocols for its Phase 2a trial for microdosing, and is developing a Phase 2 clinical trial in late-stage cancer patients.
Comparing LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects
Different forms of LSD are used in research, therefore it is important to know their difference or equivalence for correct dosing of LSD. This study compares equivalent doses of LSD base in ethanol orally, LSD tartrate in water administered orally, LSD base in an orodispersible film administered orally and LSD tartrate in water administered intravenously, as well as a placebo using a double-blind, randomized, counterballanced cross-over design in healthy participants.
This trial is being run at the University Hospital, Basel, Switzerland, with ownership rights to MindMed.
LSD Therapy for Major Depression
The team at University Hospital Basel is also working on a clinical trial entitled LSD Therapy for Persons Suffering From Major Depression: A Randomised, Double-blind, Active-placebo Controlled Phase II Study
In April 2023, the research team announced positive results from this trial, with patients receiving the high dose of LSD showing a decrease of 12.9 points (50% symptom reduction) vs a 3.6-point in the control dose. This was a significant reduction in symptoms that lasted for at least 16 weeks.
These positive results for treatment of depression could be used to strengthen the case for LSD treatment of anxiety, as the two conditions share comorbidities.
Again, this trial was at the University Hospital, Basel, Switzerland, with ownership rights to MindMed.
Low-dose LSD for the Adult ADHD
Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM-120) as Treatment for ADHD in Adults
This trial, also sponsored by MindMed, examines the safety and efficacy of repeated low dose MM-120 (MindMed’s LSD compound) as a treatment for ADHD in adults.
This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule).
The company expects topline results in late 2023.