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

NCT04968938 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: NUMCAP1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in PTSD Checklist (adapted PCL-5) total score

  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."

  18 weeks post baseline post enrollment confirmation

Study Arms (1)

MDMA-assisted therapy

EXPERIMENTAL

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

Drug: midomafetamine; Behavioral: Therapy

Interventions

midomafetamine DRUG

80 mg or 120 mg midomafetamine HCl followed by a 40 mg supplement dose

Also known as: MDMA, midomafetamine HCl

MDMA-assisted therapy

Therapy BEHAVIORAL

Manualized therapy

MDMA-assisted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lykos Therapeutics: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Devon Christie, MD

  Department of Medicine, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data and study-related documents will be available when the database has been locked and data has been unblinded.
• Access Criteria: Interested persons should correspond with the central contact for the multisite study.