Phase 2
Completed N=26
Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder
Source: ClinicalTrials.gov NCT01211405 ↗Enrolled (actual)
26
Serious AEs
4.0%
Results posted
Feb 2022
Primary outcomePrimary: Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint — -11.4; -58.3; -44.3 score on a scale
Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms?
Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which dose best reduces PTSD symptoms.
Participants will undergo three preparatory non-drug therapy sessions with a male and female co-therapist team, then undergo three day-long MDMA-assisted therapy sessions after receiving an initial dose of 30, 75, or 125 mg MDMA HCl. After each MDMA-assisted therapy session, participants will undergo three integrative therapy sessions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint |
-11.4; -58.3; -44.3 | — |
| SECONDARY Change in Global Assessment of Function (GAF) From Baseline to Primary Endpoint |
1.1; 19.4; 18.4 | — |
| SECONDARY Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint |
-11.6; 36.1; 33.7 | — |
| SECONDARY Change in Beck Depression Inventory (BDI-II) From Baseline to Primary Endpoint |
-4.6; -15.4; -24.6 | — |
| SECONDARY Change in Dissociative Experience Scale (DES-II) From Baseline to Primary Endpoint |
1.8; -8.6; -8.8 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Primary Endpoint |
1.8; -6.4; -4.8 | — |
Eligibility 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
- 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.
Data sourced from ClinicalTrials.gov (NCT01211405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.