MDMA-Assisted Therapy for PTSD
(MDMA-bCBCT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byLeslie Morland

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Dr. Leslie Morland

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this pilot trial is to examine the preliminary effectiveness of MDMA-facilitated bCBCT for improving chronic PTSD and relationship functioning in a sample of veterans and their intimate partners seeking care within the VA San Diego Healthcare System.

Eligibility Criteria

This trial is for veterans with PTSD and their partners who've been together for at least a year. Participants must speak English, commit to the study schedule, not start new mental health care during the trial, and agree to lifestyle changes. Women able to get pregnant must use birth control. Exclusions include severe relationship aggression, high risk of re-trauma or lack of support, certain psychiatric conditions or substance abuse issues.

Inclusion Criteria

Be fluent in speaking and reading English

Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone contact

I agree to fast and stop certain medications before MDMA sessions.

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Exclusion Criteria

I am a veteran with PTSD and have had ECT in the last 12 weeks.

Are likely, in the investigator's opinion and via assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation

Have a history of or a current Bipolar I disorder, Bipolar 2 disorder, or manic episode assessed via the DIAMOND and clinical interview (PTSD+ veteran only)

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Treatment Details

Interventions

MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy (Other)

Trial OverviewThe study tests if MDMA can help improve PTSD symptoms and relationship functioning when combined with brief cognitive behavioral conjoint therapy (bCBCT). Veterans with PTSD and their partners will undergo this combination treatment within the VA San Diego Healthcare System.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Non-medicine sessions of bCBCT + Medicine Sessions with 3,4-methylenedioxymethamphetamine (MDMA)Experimental Treatment2 Interventions

bCBCT Non-medicine sessions: 8 sessions MDMA Medicine sessions: Initial Dose 1: 80 mg MDMA HCl (\~68 mg MDMA) Supplementary Dose 1: 40 mg MDMA HCl (\~34 mg MDMA) Initial Dose 2: 100 mg MDMA HCl (\~84 mg MDMA) Supplementary Dose 2: 40 mg MDMA HCl (\~34 mg MDMA)