Phase 2
Completed N=28
Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
Source: ClinicalTrials.gov NCT01793610 ↗Enrolled (actual)
28
Serious AEs
2.8%
Results posted
Oct 2020
Primary outcomePrimary: Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session — -26.3; -24.4; -11.5 score on a scale
Summary
The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD.
The main questions it aims to answer are:
* Does MDMA-assisted therapy reduce PTSD symptoms?
* Is there a difference in PTSD symptoms between the 40 mg, 100 mg, and 125 mg groups?
Researchers will compare two active doses (100 mg and 125 mg) of MDMA-assisted therapy versus a comparator dose of 40 mg MDMA-assisted therapy to determine if there is a reduction in PTSD symptoms.
Participants will undergo three non-drug preparatory sessions, three MDMA-assisted therapy sessions and three non-drug integrative therapy sessions after each MDMA-assisted therapy session.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session |
-26.3; -24.4; -11.5 | — |
| SECONDARY Change in PTSD Diagnostic Scale (PDS) From Baseline to One Month Post 2nd Experimental Session |
-11.3; -10.0; -4.2 | — |
| SECONDARY Change in Beck Depression Inventory II (BDI-II) From Baseline to One Month Post 2nd Experimental Session |
-11.0; -9.9; -11.5 | — |
| SECONDARY Change in Global Assessment of Functioning (GAF) Total Score From Baseline to One Month Post 2nd Experimental Session |
0.6; 2.4; 1.5 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to One Month Post 2nd Experimental Session |
-2.0; -3.6; -0.8 | — |
| SECONDARY Change in Dissociative Experiences Scale (DES-II) From Baseline to One Month Post 2nd Experimental Session |
-5.9; -13.3; -0.2 | — |
| SECONDARY Change in Posttraumatic Growth Inventory (PTGI) From Baseline to One Month Post 2nd Experimental Session |
15.0; 16.2; 3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic PTSD for six months or longer.
- Have a CAPS score showing moderate to severe PTSD symptoms.
- 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.
- Are willing to refrain from taking any psychiatric medications during the study period.
- Willing to follow restrictions and guidelines concerning consumption of food, beverages or nicotine the night before and just prior to each MDMA session.
- Willing to remain overnight at the study site.
- Are willing to be driven home after experimental sessions either by a driver they arrange, a taxi, or study personnel.
- Are willing to be contacted via telephone by study personnel.
- If of child-bearing age, must have a negative pregnancy and agree to use an effective form of birth control.
- Must provide a personal contact who is willing to be reached in case of emergency.
- Agree to let the investigators know within 48 hours of any planned medical interventions.
- Are proficient in reading and speaking English.
- Agree to have all psychotherapy sessions recorded.
- Agree not to participate in any other interventional clinical trials during the course of the study.
Exclusion Criteria
- Are pregnant or nursing, or if of child-bearing age and do not use an effective means of birth control.
- Weigh less than 48 kg.
- Meet DSM-IV criteria for substance abuse or dependence for any substance in the past 60 days.
- Have used "Ecstasy" (material represented as containing MDMA) more than five times in the last ten years or at least once within 6 months of the MDMA session.
- 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 in the study.
Data sourced from ClinicalTrials.gov (NCT01793610). 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.