CompletedPhase 2MDMA

MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

NCT ID

NCT00090064

Target Enrollment

23 participants

Start Date

2004-03-12

Est. Completion

2010-06-21

About This Study

The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy? Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA HCl, or placebo, followed by a dose of 62.5 mg of MDMA HCl, or placebo. During this treatment period, participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions. The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period.

Conditions Studied

Posttraumatic Stress Disorder

Interventions

•Midomafetamine HCl
•Lactose placebo pill
•Therapy

Eligibility

Age:18 Years - 70 Years

Healthy Volunteers:No

View full eligibility criteria

Inclusion Criteria:

* Have current PTSD (within the past 6 months) in response to crime victimization, including childhood sexual or physical abuse, or meet criteria for PTSD in response to combat;
* Have a CAPS score showing moderate to severe PTSD symptoms;
* They must either:

  1. Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and psychotherapy;
  2. Be a veteran with PTSD symptoms that have endured for no less than one year but no more than five years
* Be at least 18 years old;
* Must be generally healthy;
* Willing to remain overnight at the study site;
* Agree to have transportation home the morning after experimental sessions;
* 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;
* Are proficient in reading English;

Exclusion Criteria:

* Are pregnant or nursing, or are able to bear children and are not practicing an effective means of birth control;
* Weigh less than 50 kg or more than 105 kg;
* Are unable to give adequate informed consent;
* Prior use of "Ecstasy" (illicit drug preparations purported to contain MDMA) more than 5 times or at any time within the previous 6 months;
* Have a history of certain excluded medical disorders.

Study Locations (1)

Offices of Michael Mithoefer MD