Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-17

Study Completion Date

2023-12-04

Brief Summary

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This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

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Detailed Description

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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).

Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes.

There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.

Conditions

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ADHD Attention Deficit Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1- Placebo

A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A treatment which is designed to have no therapeutic value.

Arm 2- MM-120

A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.

Group Type EXPERIMENTAL

MM-120

Intervention Type DRUG

MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.

Interventions

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MM-120

MM-120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM-120 manifests primarily visual, as well as auditory, hallucinations.

Intervention Type DRUG

Placebo

A treatment which is designed to have no therapeutic value.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients ≥ 18 and ≤ 65 years of age at Screening
* Patients with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured interview (MINI).
* Adequate organ function.
* Able to understand the study procedures and understand risks associated with the study, and sign written informed consent to participate in the study.
* Must be willing to refrain from more than 6 standard alcoholic drinks a week, more than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment period (6 weeks) and until the last study visit is complete.

Exclusion Criteria

* Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder.
* Past or present bipolar disorder (DSM-5).
* Any lifetime history of suicide attempt.
* Once Informed Consent form is signed, not willing or able to stop any prescription or non-prescription ADHD medications.
* Use of investigational medication/treatment in the past 30 days.
* Patients with a positive urine drug screen with the exception of THC or its metabolites.
* Pregnant or nursing females.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No