Phase 2
Completed N=3
Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial
Source: ClinicalTrials.gov NCT01458327 ↗Enrolled (actual)
3
Serious AEs
33.3%
Results posted
Nov 2021
Primary outcomePrimary: Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) — 93.3 score on a scale
Summary
This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) |
93.3 | — |
| PRIMARY Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up |
31.3 | — |
| PRIMARY Clinician-Administered PTSD Scale (CAPS-IV)) at 12-month Follow-up |
52.7 | — |
| PRIMARY Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up |
-62.0 | — |
| PRIMARY Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 12-month Follow-up |
-40.7 | — |
Eligibility Criteria
Inclusion Criteria
- Be diagnosed with chronic PTSD;
- Have a CAPS score showing moderate to severe PTSD symptoms;
- Have participated in MP-1;
- 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;
- 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 (NCT01458327). 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.