MDMA-Assisted Psychotherapy for PTSD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Southern California

Must not be taking: Psychiatric medications

Disqualifiers: Psychotic disorder, Bipolar, Eating disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an add-on substudy to an already-approved clinical trial "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD" (ClinicalTrials.gov Identifier: NCT03537014) which is to be a phase 3 clinical trial studying the efficacy of MDMA-Assisted Psychotherapy for Post Traumatic Stress Disorder. The parent study has been approved by Copernicus Group IRB and is being run by the MAPS Public Benefit Corporation, and is a randomized controlled trial comparing the clinical efficacy of MDMA-assisted psychotherapy to Placebo-assisted psychotherapy. The parent study will recruit participants with Post Traumatic Stress Disorder and involves 20 total study visits over the course of 18 weeks including 3 preparatory psychotherapy visits plus 3 separate treatment sessions involving psychotherapy plus the administration of MDMA vs. placebo and 3 follow up psychotherapy visits after each treatment session. This substudy adds on the collection of saliva in a salivary DNA collection kit at baseline and after treatment to the parent study clinical trail so as to assess whether the MDMA-Assisted Psychotherapy exerts influence on the epigenetic regulation of stress-associated genes as assessed in the salivary epithelial and white blood cells of the research participants. We aim to further assess whether any such changes are correlated with improvements in PTSD symptoms.

Research Team

Rael Cahn, MD, PhD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for individuals with Post-Traumatic Stress Disorder (PTSD) who are already participating in a Phase 3 study of MDMA-Assisted Psychotherapy. Participants will provide saliva samples to explore if the therapy affects stress-related genes.

Inclusion Criteria

At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of 6 months or longer

I can fluently speak and read the main language used at the study site.

I have severe PTSD symptoms with a PCL-5 score of 50 or more.

Exclusion Criteria

Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial

I need medications that can affect my heart's electrical cycle during the trial.

Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Psychotherapy

Participants undergo 3 preparatory psychotherapy visits before treatment sessions

3 weeks

3 visits (in-person)

Treatment

Participants receive MDMA or placebo during 3 treatment sessions with psychotherapy

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 3 follow-up psychotherapy visits

3 weeks

3 visits (in-person)

Saliva Collection

Saliva samples are collected at baseline and after the final treatment session to assess epigenetic changes

18 weeks

2 visits (in-person)

Treatment Details

Interventions

• MDMA-Assisted Psychotherapy

Trial Overview The substudy tests whether MDMA-assisted psychotherapy can influence epigenetic markers in saliva that relate to stress. It's an addition to a larger study comparing this treatment with placebo-assisted psychotherapy over several sessions.

Participant Groups

Group I: MDMA Assisted Psychotherapy Active Control 2 Interventions

A longitudinal course of psychotherapy with administration of MDMA on two occasions to assist with the psychotherapeutic process

Group II: Placebo Assisted Psychotherapy Placebo Group 1 Intervention

A longitudinal course of psychotherapy with administration of placebo on two occasions to assist with the psychotherapeutic process

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Lykos Therapeutics

Collaborator

Trials

12

Recruited

330+

Multidisciplinary Association for Psychedelic Studies

Collaborator

Trials

40

Recruited

1,200+