WithdrawnPhase 2MDMA

Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

Sponsored by Lykos Therapeutics

NCT ID
NCT04968938
Start Date
2022-08
Est. Completion
2023-08

About This Study

The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD. The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.

Conditions Studied

Posttraumatic Stress Disorder

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 fluent in speaking and reading a recognized language of the study site.
* Are able to swallow pills.
* Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions.
* Must provide a contact (relative, spouse, close friend, or other support person) 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 of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
* Must not participate in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
* At baseline, have moderate PTSD diagnosis.

Exclusion Criteria:

* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] in males and\>460 ms in females corrected by Friderica's formula).
* 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 disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
* Have current alcohol or substance use disorders.

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source