Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (MPG1)

Lykos Therapeutics

Status and phase

Withdrawn

Phase 2

Conditions

PTSD

Treatments

Behavioral: Therapy

Drug: Midomafetamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05173831

MPG1

Details and patient eligibility

About

The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD.

The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms?

Participants will undergo non-drug preparatory therapy sessions before their MDMA-assisted therapy sessions. After, they will undergo non-drug integrative therapy sessions.

Full description

To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a Phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA (120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later), along with non-drug preparatory and integrative therapy administered in both individual and group sessions.

The Primary Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are at least 18 years old.
Are a U.S. Military Veteran
Are fluent in speaking and reading the predominantly used or recognized language of the study site.
Are able to swallow pills.
Agree to have study visits recorded, including Experimental Sessions, outcome assessments, and non-drug psychotherapy sessions.
Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
Must not participate in any other interventional clinical trials during the duration of the study.
Have a current PTSD diagnosis at the time of screening.

Exclusion criteria

Are not able to give adequate informed consent.
Have uncontrolled hypertension.
Have a marked baseline QTcF interval >450 milliseconds [ms] demonstrated on repeated ECG assessments.
Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Have evidence or history of significant medical disorders.
Have symptomatic liver or biliary disease.
Have history of hyponatremia or hyperthermia.
Weigh less than 48 kilograms (kg).
Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
Have an active illicit drug or prescription drug substance use disorder