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CompletedPhase 2Results posted

Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial

NCT01458327 · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 2
Phase
3
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)

    Measured over Less than 4 weeks before first experimental session

  • Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up

    Measured over 2 months post experimental session

  • Clinician-Administered PTSD Scale (CAPS-IV)) at 12-month Follow-up

    Measured over 12 months post experimental session

  • Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up

    Measured over Baseline to 2 months post experimental session

  • Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 12-month Follow-up

    Measured over Baseline to 12 months post experimental session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Offices of Michael MithoeferMt. PleasantSouth CarolinaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01458327 on ClinicalTrials.gov →

Last updated in the registry 2024-01-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits