WithdrawnPhase 2MDMA

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

Sponsored by Lykos Therapeutics

NCT ID
NCT05173831
0
Start Date
2023-09
Est. Completion
2024-12

About This Study

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.

Conditions Studied

PTSD

Interventions

  • Midomafetamine
  • Therapy

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
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

This trial is not recruiting

This study is currently not accepting new participants.

Find recruiting trials
Data Source
ClinicalTrials.gov

Last updated from source

Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans | Huxley