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

NCT05173831 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MPG1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

PTSD

Outcome Measures

Primary Outcomes (1)

• Change in CAPS-5 Total Severity Score

  The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure \[114\], including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score \[114\]. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  Baseline - 3 months from first Experimental Session

Secondary Outcomes (1)

• Change in Sheehan Disability Scale (SDS)

  Baseline - 3 months from First Experimental Session

Study Arms (1)

Two Sessions of MDMA-assisted therapy

EXPERIMENTAL

Two MDMA-assisted Therapy Sessions with 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later

Drug: Midomafetamine; Behavioral: Therapy

Interventions

Midomafetamine DRUG

Initial dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later

Also known as: 3,4-methylenedioxymethamphetamine, MDMA

Two Sessions of MDMA-assisted therapy

Therapy BEHAVIORAL

Manualized therapy performed by therapist team

Two Sessions of 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 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.

You may not qualify if:

• 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

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

• Chris Stauffer, MD

  Associate Professor of Psychiatry at Oregon Health & Science University

  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

Model Details: Open-label study examining safety and effects of two sessions of MDMA-assisted therapy each followed by four integrative therapy sessions

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10