A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
Observation window: During the Treatment Period from the first Experimental Session to the last Integrative Session (approximately 12 weeks)
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.
| Adverse event | MDMA-assisted Therapy n = 53 | Placebo With Therapy n = 51 |
|---|---|---|
| Overall | ||
| Serious adverse events | 0/530% | 0/510% |
| Any non-serious event | 53/53100% | 49/5196% |
| Deaths | 0/530% | 0/510% |
| Most frequent events | ||
| Headache Nervous system disorders | 38/5372% | 31/5161% |
| Muscle tightness Musculoskeletal and connective tissue disorders | 31/5358% | 13/5125% |
| Nausea Gastrointestinal disorders | 24/5345% | 11/5122% |
| Suicidal ideation Psychiatric disorders | 18/5334% | 21/5141% |
| Decreased appetite Metabolism and nutrition disorders | 19/5336% | 5/5110% |
| Insomnia Psychiatric disorders | 19/5336% | 15/5129% |
| Hyperhidrosis Skin and subcutaneous tissue disorders | 18/5334% | 3/516% |
| Dizziness Nervous system disorders | 15/5328% | 8/5116% |
| Anxiety Psychiatric disorders | 15/5328% | 12/5124% |
| Fatigue General disorders | 14/5326% | 9/5118% |
| Feeling hot General disorders | 14/5326% | 6/5112% |
| Feeling cold General disorders | 11/5321% | 3/516% |