CompletedPhase 2MDMA

Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD

NCT ID

NCT01793610

Target Enrollment

29 participants

Start Date

2013-05-13

Est. Completion

2017-02-01

About This Study

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.

Conditions Studied

Posttraumatic Stress Disorder

Interventions

•Comparator Dose (40mg) MDMA HCl
•Active Dose 2 (100 mg) MDMA HCl
•Active Dose 1 (125 mg) MDMA HCl
•Psychotherapy

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full 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.

Study Locations (1)

Offices of Marcela d'Otalora