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3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial
| Content Provider | SAGE Publishing |
|---|---|
| Author | Marcela Ot’alora, G. Grigsby, Jim Poulter, Bruce Joseph W Van Derveer, III Giron, Sara Gael Jerome, Lisa Feduccia, Allison A. Hamilton, Scott Yazar-Klosinski, Berra Emerson, Amy Mithoefer, Michael C. Doblin, Rick |
| Copyright Year | 2018 |
| Abstract | Posttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms.Aims:This pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams.Methods:Twenty-eight people with chronic posttraumatic stress disorder were randomized in a double-blind dose response comparison of two active doses (100 and 125 mg) with a low dose (40 mg) of MDMA administered during eight-hour psychotherapy sessions. Change in the Clinician-Administered PTSD Scale total scores one month after two sessions of MDMA served as the primary outcome. Active dose groups had one additional open-label session; the low dose group crossed over for three open-label active dose sessions. A 12-month follow-up assessment occurred after the final MDMA session.Results:In the intent-to-treat set, the active groups had the largest reduction in Clinician-Administered PTSD Scale total scores at the primary endpoint, with mean (standard deviation) changes of −26.3 (29.5) for 125 mg, −24.4 (24.2) for 100 mg, and −11.5 (21.2) for 40 mg, though statistical significance was reached only in the per protocol set (p=0.03). Posttraumatic stress disorder symptoms remained lower than baseline at 12-month follow-up (p<0.001) with 76% (n=25) not meeting posttraumatic stress disorder criteria. There were no drug-related serious adverse events, and the treatment was well-tolerated.Conclusions:Our findings support previous investigations of MDMA-assisted psychotherapy as an innovative, efficacious treatment for posttraumatic stress disorder. |
| Related Links | https://journals.sagepub.com/doi/pdf/10.1177/0269881118806297?download=true |
| Starting Page | 1295 |
| Ending Page | 1307 |
| Page Count | 13 |
| ISSN | 02698811 |
| Issue Number | 12 |
| Volume Number | 32 |
| Journal | Journal of Psychopharmacology (JOP) |
| e-ISSN | 14617285 |
| DOI | 10.1177/0269881118806297 |
| Language | English |
| Publisher | Sage Publications UK |
| Publisher Date | 2018-10-29 |
| Publisher Place | London |
| Access Restriction | Open |
| Rights Holder | © The Author(s) 2018 |
| Subject Keyword | sleep disturbance oxytocin serotonin depression posttraumatic stress disorder 3,4-Methylenedioxymethamphetamine (MDMA) |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology Pharmacology (medical) Psychiatry and Mental Health |
