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

Phase 2

Withdrawn

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: midomafetamine; Behavioral: Therapy

• Registration Number: NCT04968938
• Lead Sponsor: Lykos Therapeutics

Brief Summary

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.

Detailed Description

This Phase 2, open-label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with PTSD. This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants.

The Preparatory Period will consist of three 90-minute non-drug preparatory therapy sessions. A flexible divided dose of MDMA will be administered during the Treatment Period with manualized therapy in up to two open-label experimental sessions. During the Treatment Period, each experimental session is followed by three 90-minute non-drug integrative therapy sessions. The experimental sessions are scheduled roughly 3 to 5 weeks apart.

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-20
• Study Start: 2022-08
• Primary Completion: 2023-08
• Study Completion: 2023-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDMA-assisted therapy	midomafetamine	Two sessions of MDMA-assisted therapy with an initial dose of 80 mg or 120 mg midomafetamine HCl and optional supplemental dose of 40 mg 1.5 to 2 hours later
MDMA-assisted therapy	Therapy	Two sessions of MDMA-assisted therapy with an initial dose of 80 mg or 120 mg midomafetamine HCl and optional supplemental dose of 40 mg 1.5 to 2 hours later

Primary Outcome Measures

Name	Time	Method
Change from Baseline in PTSD Checklist (adapted PCL-5) total score	18 weeks post baseline post enrollment confirmation	20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the symptoms of PTSD per DSM-5. The gold standard for diagnosing PTSD is a structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS-5). When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis.The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."