MDMA-Assisted Psychotherapy for PTSD

(VALLMDMA_001 Trial)

Overseen By Angela J Hawley, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Loma Linda Health Care System

Must not be taking: Anticonvulsants, Psychoactive medications

Disqualifiers: Psychotic disorder, Bipolar, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 9

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System. The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected. The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.

Who Is on the Research Team?

Shannon Remick, MD

Principal Investigator

Staff Psychiatrist

Are You a Good Fit for This Trial?

This trial is for US military veterans aged 18-55 with combat-related PTSD that hasn't improved after treatment, enrolled in VA healthcare. They must be generally healthy, not on psychiatric meds (or willing to stop them safely), and agree to avoid alcohol before sessions and certain medications during the study. Pregnant women or those at serious suicide risk are excluded.

Inclusion Criteria

Are willing to follow restrictions and guidelines concerning medications, consumption of food, beverages, alcohol, nicotine, or illicit substances

Must agree to inform the investigators within 48 hours of any medical conditions and procedures

I am generally healthy with no major health issues.

Exclusion Criteria

Lack a stable living situation or supportive system

Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist

I do not have severe health issues like heart, lung, liver diseases, or immune problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preparatory Psychotherapy

Three preparatory psychotherapy sessions spaced approximately one week apart

3 weeks

3 visits (in-person)

Experimental Treatment

Three single-dose MDMA-assisted psychotherapy sessions with integrative follow-up sessions

12 weeks

3 experimental sessions, 9 integrative follow-up sessions (in-person)

Primary Endpoint Assessment

Assessment of primary endpoint 2 months after the last experimental session

2 months

1 visit (in-person)

Long-term Follow-up

Assessment of long-term effects 12 months after the last MDMA session

12 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 3,4-methylenedioxymethamphetamine (MDMA)

Trial Overview The trial tests MDMA-assisted psychotherapy's effectiveness for veterans with refractory PTSD over a 12-week period, including three single-dose sessions paired with therapy. The main goal is symptom reduction or remission measured by the Clinician-Administered PTSD Scale (CAPS-5).

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 Intervention

Participants will receive an initial dose of 80 mg of 3,4-methylenedioxymethamphetamine (MDMA) and an optional supplemental dose of 40 mg MDMA during the first Experimental Session. In the second and third Experimental Sessions, the participant will receive an initial dose of 120 mg MDMA and an optional supplemental dose of 40 mg MDMA.

Who Is Running the Clinical Trial?

VA Loma Linda Health Care System

Lead Sponsor

Trials

10

Recruited

770+

Lykos Therapeutics

Collaborator

Trials

12

Recruited

330+

Multidisciplinary Association for Psychedelic Studies

Collaborator

Trials

40

Recruited

1,200+