NCT05200936

Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial

Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM120) as Treatment for ADHD in Adults: a Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2a Proof of Concept Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Definium Therapeutics US, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study measures the safety and efficacy of repeated low dose MM120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

Detailed description

This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule). Low dose MM120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes. There will be a 1:1 randomization, double-blind, to MM120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.

Conditions

• ADHD
• Attention Deficit Disorder

Interventions

Type	Name	Description
DRUG	MM120	MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations.
OTHER	Placebo	A treatment which is designed to have no therapeutic value.

Timeline

• Start date: 2021-12-17
• Primary completion: 2023-11-06
• Completion: 2023-12-04
• First posted: 2022-01-21
• Last updated: 2026-02-27
• Results posted: 2025-04-13

Locations

2 sites across 2 countries: Netherlands, Switzerland