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MDMA-Assisted Psychotherapy for PTSD (MAPPUSX Trial)

Phase 3
Waitlist Available
Research Sponsored by MAPS Public Benefit Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline enrollment to approximately 18 weeks later (visit 16 occurs 24 to 32 days after experimental session 3)
Awards & highlights

Summary

This trial is studying whether MDMA (also known as “ecstasy”) can help relieve symptoms of post-traumatic stress disorder (PTSD). Researchers will give participants 3 doses of MDMA during 8 psychotherapy sessions over 12 weeks. They will measure the participants’ PTSD symptoms before and after the treatment period to see if MDMA helped.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline enrollment to approximately 18 weeks later (visit 16 occurs 24 to 32 days after experimental session 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline enrollment to approximately 18 weeks later (visit 16 occurs 24 to 32 days after experimental session 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Visit 16 in PCL-5 total score
Secondary outcome measures
Change from Baseline to Visit 16 in Sheehan Disability Scale (SDS) total score

Side effects data

From 2020 Phase 3 trial • 100 Patients • NCT03537014
72%
Headache
61%
Muscle Tightness
52%
Decreased Appetite
46%
Suicidal Ideation
43%
Insomnia
33%
Anxiety
30%
Fatigue
30%
Nausea
26%
Viral Upper Respiratory Tract Infection
22%
Hyperhidrosis
20%
Feeling Cold
20%
Dizziness
15%
Nightmare
15%
Asthenia
15%
Mydriasis
15%
Restlnessness
13%
Dizziness Postural
13%
Nystagmus
13%
Tremor
13%
Bruxism
13%
Abdominal Discomfort
11%
Feeling Jittery
11%
Dry Mouth
11%
Back Pain
11%
Depressed Mood
11%
Upper Respiratory Tract Infection
11%
Blood Pressure Increased
11%
Paraesthesia
11%
Abdominal Pain Upper
9%
Musculoskeletal Pain
9%
Vomiting
9%
Feeling Hot
9%
Palpitations
9%
Non-Cardiac Chest Pain
9%
Vision Blurred
9%
Depression
9%
Disturbance in Attention
9%
Stress
9%
Intrusive Thoughts
9%
Pain
9%
Pollakiuria
9%
Feeling of Body Temperature Change
9%
Arthralgia
9%
Temperature Intolerence
7%
Muscle Spasms
7%
Micturition Urgency
7%
Chills
7%
Muscle Twitching
7%
Flashback
7%
Pain in Jaw
7%
Anger
7%
Nervousness
7%
Feeling Abnormal
7%
Hypoaesthesia
7%
Somnolence
7%
Substance Use
7%
Ear Pain
7%
Myalgia
7%
Vertigo
7%
Influenza
7%
Dysmenorrhoea
7%
Pyrexia
4%
Influenza Like Illness
4%
Diarrhea
4%
Emotional Disorder
4%
Irritability
4%
Neck Pain
4%
Agitation
4%
Oropharyngeal Pain
4%
Emotional Distress
4%
Dissociation
4%
Panic Attack
2%
Intentional Self-Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
MDMA-assisted Therapy
Placebo With Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: MDMA-assisted therapyExperimental Treatment1 Intervention
Three open-label sessions of MDMA-assisted therapy with flexible dose of MDMA (80 or 120 mg) and optional supplemental dose of (40 or 60 mg), 1.5 to 2 hours later
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midomafetamine
2014
Completed Phase 3
~310

Find a Location

Who is running the clinical trial?

MAPS Public Benefit CorporationLead Sponsor
29 Previous Clinical Trials
1,217 Total Patients Enrolled
Lykos TherapeuticsLead Sponsor
41 Previous Clinical Trials
1,554 Total Patients Enrolled
Multidisciplinary Association for Psychedelic StudiesLead Sponsor
39 Previous Clinical Trials
1,528 Total Patients Enrolled
~20 spots leftby Jul 2025
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