A Test of MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
This Phase II, triple-blind, randomised, placebo-controlled study (n=23) evaluates MDMA-assisted therapy (125 mg + 62.5 mg) across two 8-hour sessions for chronic, treatment-resistant PTSD.
Detailed Description
Randomised, triple-blind, placebo-controlled trial comparing MDMA-assisted psychotherapy with psychotherapy plus inactive placebo in adults with chronic, treatment-resistant PTSD, including veterans.
Participants received two blinded 8-hour sessions (125 mg oral MDMA with a 62.5 mg supplemental dose, or matched placebo), with preparatory and integration therapy. Primary outcome: change in CAPS-IV two months post-treatment.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-AT
experimentalTwo 8-hour MDMA-assisted psychotherapy sessions with a divided dose (125 mg + 62.5 mg).
Interventions
- MDMA125 mgvia Oral• two sessions• 2 doses total
Supplemental 62.5 mg 2–2.5 h after initial dose.
Placebo + therapy
inactiveTwo 8-hour psychotherapy sessions with inactive placebo.
Interventions
- Placebovia Oral• two sessions• 2 doses total
Participants
Inclusion Criteria
- Inclusion Criteria:
- Have current PTSD (within the past 6 months) in response to crime victimization, including childhood sexual or physical abuse, or meet criteria for PTSD in response to combat;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- They must either:
- 1. Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and psychotherapy;
- 2. Be a veteran with PTSD symptoms that have endured for no less than one year but no more than five years
- Be at least 18 years old;
- Must be generally healthy;
- Willing to remain overnight at the study site;
- Agree to have transportation home the morning after experimental sessions;
- Are willing to be contacted via telephone for all necessary telephone contacts;
- Must have a negative pregnancy test if able to bear children and agree to use an effective form of birth control;
- Are proficient in reading English;
Exclusion Criteria
- Exclusion Criteria:
- Are pregnant or nursing, or are able to bear children and are not practicing an effective means of birth control;
- Weigh less than 50 kg or more than 105 kg;
- Are unable to give adequate informed consent;
- Prior use of Ecstasy (illicit drug preparations purported to contain MDMA) more than 5 times or at any time within the previous 6 months;
- Have a history of certain excluded medical disorders.