Study Comparing Three Doses of MDMA Along With Psychotherapy in Veterans With Posttraumatic Stress Disorder
Randomized, double-blind, dose-comparison Phase II study (n=26) testing 30 mg, 75 mg, and 125 mg MDMA HCl plus psychotherapy in veterans with chronic PTSD.
Detailed Description
Participants received preparatory non-drug therapy sessions then two blinded eight-hour MDMA-assisted therapy sessions (125 mg group received a third open-label session); supplemental half-dose given 1.5–2.5 hours after initial dose when agreed.
Outcomes include PTSD and depression symptoms, quality of life, posttraumatic growth, vital signs and adverse events assessed acutely and at follow-ups up to 12 months.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Low dose
active comparator30 mg MDMA HCl with psychotherapy (two blinded sessions; possible open-label crossover).
Interventions
- MDMA30 mgvia Oral• single dose• 2 doses total
Supplemental half-dose (15 mg) 1.5–2.5 h after initial; two blinded sessions; may enter open-label crossover with three sessions.
- Compoundvia Other
Non-directive psychotherapy with male and female co-therapist; preparatory and integration sessions
Medium dose
active comparator75 mg MDMA HCl with psychotherapy (two blinded sessions; possible open-label crossover).
Interventions
- MDMA75 mgvia Oral• single dose• 2 doses total
Supplemental half-dose (37.5 mg) 1.5–2.5 h after initial; two blinded sessions; may enter open-label crossover.
- Compoundvia Other
Non-directive psychotherapy with male and female co-therapist; preparatory and integration sessions
Full dose
experimental125 mg MDMA HCl with psychotherapy (two blinded sessions plus a third open-label session).
Interventions
- MDMA125 mgvia Oral• single dose• 2 doses total
Supplemental half-dose (62.5 mg) 1.5–2.5 h after initial; receives a third open-label experimental session.
- Compoundvia Other
Non-directive psychotherapy with male and female co-therapist; preparatory and integration sessions
Participants
Inclusion Criteria
- Inclusion Criteria:
- Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.
- Are at least 18 years old;
- Must be generally healthy;
- Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
- Are willing to refrain from taking any psychiatric medications during the study period;
- Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
- Willing to remain overnight at the study site;
- Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
- 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;
- Must provide a contact in the event of a participant becoming suicidal;
- Are proficient in speaking and reading English;
- Agree to have all clinic visit sessions recorded to audio and video
- Agree not to participate in any other interventional clinical trials during the duration of this study.
Exclusion Criteria
- Exclusion Criteria:
- Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
- Weigh less than 48 kg;
- Are abusing illegal drugs;
- Have used ecstasy (material representing itself as MDMA) more than 5 times or at least once in the last 6 months;
- Are unable to give adequate informed consent;
- Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
- Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation.