Progress and promise for the MDMA drug development program.
Study Goal
The researchers aimed to determine whether MDMA, administered in conjunction with psychotherapy, could enhance treatment effectiveness for PTSD.
Results Summary
Phase 2 clinical trials demonstrated favorable safety outcomes and large effect sizes for MDMA-assisted psychotherapy in PTSD treatment, prompting further investigation in phase 3 trials. Brain imaging and animal models suggest MDMA affects emotion and memory processing, though more research is needed on its mechanisms.
Population
Patients with posttraumatic stress disorder (PTSD).
Effective Dosage
Not specified in the abstract.
Duration
Administered on only a few occasions (exact duration not specified).
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
MDMA-assisted psychotherapy | no change | safety outcomes | patients with PTSD | favorable | show favorable safety outcomes | #1 |
MDMA-assisted psychotherapy | increase | effect sizes | patients with PTSD | large | show large effect sizes | #2 |
MDMA | increase | effectiveness of psychotherapy | - | - | can increase the effectiveness | #3 |
MDMA | increase | hormones and neurochemicals | - | - | stimulates the release | #4 |
MDMA | neutral | key brain areas for emotion and memory processing | - | - | affect key brain areas | #5 |
MDMA | neutral | psychological processing | - | robust | robust effects | #6 |
Pharmacotherapy is often used to target symptoms of posttraumatic stress disorder (PTSD), but does not provide definitive treatment, and side effects of daily medication are often problematic. Trauma-focused psychotherapies are more likely than drug treatment to achieve PTSD remission, but have high dropout rates and ineffective for a large percentage of patients. Therefore, research into drugs that might increase the effectiveness of psychotherapy is a logical avenue of investigation. The most promising drug studied as a catalyst to psychotherapy for PTSD thus far is 3,4-methylenedioxymethamphetamine (MDMA), commonly known as the recreational drug "Ecstasy." MDMA stimulates the release of hormones and neurochemicals that affect key brain areas for emotion and memory processing. A series of recently completed phase 2 clinical trials of MDMA-assisted psychotherapy for treatment of PTSD show favorable safety outcomes and large effect sizes that warrant expansion into multi-site phase 3 trials, set to commence in 2018. The nonprofit sponsor of the MDMA drug development program, the Multidisciplinary Association for Psychedelic Studies (MAPS), is supporting these trials to explore whether MDMA, administered on only a few occasions, can increase the effectiveness of psychotherapy. Brain imaging techniques and animal models of fear extinction are elucidating neural mechanisms underlying the robust effects of MDMA on psychological processing; however, much remains to be learned about the complexities of MDMA effects as well as the complexities of PTSD itself.