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MAPS Study
Investigating MDMA as a Possible Treatment
for Post-Traumatic Stress Disorder (PTSD)
by Erowid
v1.0 - Feb 2004
NEWS: MAPS's research team has received DEA permission to go ahead with their FDA-approved research into the therapeutic potential of MDMA.

See also MAPS's MDMA Research Page for more information.

One of MAPS's longest term goals has been to sponsor clinical research into the beneficial therapeutic potential of MDMA. Many underground therapists, starting in the 1970s, have claimed that MDMA can be very effective for certain types of therapy, but these assertions have never been tested in any published scientific research.

After a number of years of having trouble finding established researchers willing to take on the political hot potato of ecstasy-benefit research, and finding that NIDA (the organization that funds nearly all research into controlled substances) was unwilling to provide assistance, MAPS began a project in 1999 to initiate its own research, find set of researchers, secure a location, get FDA and DEA approval, and move ahead on its own.

The MAPS study protocol was worked out among several groups of experts over the first year. The study had to be designed with a very small number of people receiving the MDMA in a 'safety study' design because it is the first of its kind. The complexities of human subjects research using controlled substances in the United States could easily take a several-volume encyclopedia to describe, but the simplest summary is that the FDA and the ethics committees (called Institutional Review Boards [IRBs] or human subjects committees) tightly restrict how preliminary research is done. The first study of this type is, by necessity, extremely limited and cannot make conclusive determinations about the effectiveness of MDMA as a therapy.

This Phase 1 safety study is designed to approximate what a larger study might look like, including involvement wtih a therapist, outcome measures, placebo controls, patient screening procedures, emergency situation management plans, and use of the MDMA in a well-planned, controlled environment. If this small study can safely administer MDMA to the patients, no serious abreactions occur, and the study design results in some interesting data, then a second study can take place which improves the protocols and increases the number of people involved. Again: it is not possible with a safety study of this size to prove general therapeutic effectiveness and this is not the goal of this phase of research.

The study involves 20 people who have been diagnosed with Post-Traumatic Stress Disorder (PTSD) and have failed to respond to other pharmacological treatments. All of the participants will be screened for health concerns and excluded from the study if they are considered higher risk (e.g. if they have heart ailments or other cardiovascular problems). All of the participants will receive about 12 hours of non-drug, face-to-face therapy with a trained psychotherapist. Twelve (12) of the subjects will receive two sessions of MDMA (at around 125 mg per session) 3-5 weeks apart, while 8 subjects will receive 2 similar sessions with placebo instead.

The main outcome measures are PTSD symptom evaluations given both before and after the 12 week therapy treatment, done by researchers who are blind to who received the MDMA and who received the placebo.

More Information about this Study:
News:
  • The Village Voice: The Ecstasy Factor, March 10, 2004
  • CNN : Ecstasy approved for medical study, Feb 25 2004

  • Errors in CNN Story: (by IJ)
    1. The US study of MDMA-assisted psychotherapy in people with PTSD is open to both men and women, not just women, who have PTSD as a result of any crime-related trauma.

    2. All subjects not receiving the placebo will receive exactly two doses of 125 mg MDMA, and not "one or two doses."

    3. Commenting on Dr. Lillienfeld's comment that "Everyone will know" who received MDMA and who received the placebo: The consultant assessing volunteers for PTSD symptoms will not be present during experimental (MDMA or placebo) sessions, and will not have access to the data taken during these sessions (e.g. physiological measurements).

  • http://www.washingtonpost.com/ac2/wp-dyn/A20813-2004Mar1?language=printer, Washington Post March 2 2004