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Home » Dependent personality disorder

Psychiatric Times. Vol. 28 No. 5
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Clinical Psychopharmacology 

Does MDMA Have a Role in Clinical Psychiatry?

By Michael C. Mithoefer, MD | May 6, 2011
Dr Mithoefer is in private practice of psychiatry and clinical research in Mount Pleasant, SC. Dr Mithoefer reports that he receives funding from the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit organization for conducting research, protocol development, and training of other researchers, and for acting as medical monitor for other studies.

Like every drug or technology that has therapeutic value, MDMA (3,4-methylenedioxymethamphetamine) has potential risks and benefits. Unlike most other drugs under clinical investigation, MDMA has a complex and controversial history that has delayed dispassionate scientific investigation into its therapeutic use. Fortunately, research efforts are now overcoming the liabilities of this history, and rigorous research that explores whether MDMA has a role in psychopharmacology is under way.

(MORE: Ethical Issues in Psychopharmacology)

MDMA was neither an approved medication nor an illegal substance, but as it was increasingly marketed under the name “ecstasy” and as recreational use grew, it eventually drew the attention of lawmakers. In 1985, the Drug Enforcement Administration (DEA) deemed MDMA a Schedule 1 substance despite the testimony of physicians and the recommendation of an administrative law judge who suggested that it be a Schedule 3 substance.5 Following this decision, clinical research with MDMA was severely curtailed, but in the past several years it has been gaining momentum.

Recent research

A number of phase 1 safety studies have been done in the United States and Europe, and a phase 2 trial was started in Spain but halted for political reasons unrelated to drug safety.6-15 Additional phase 2 trials are under way in the United States and Switzerland and will soon begin in Israel, Jordan, and Canada. With the exception of 1 study of anxiety associated with advanced stage cancer in the United States, these trials are all directed at studying MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD).

It is noteworthy that all of these clinical trials are using MDMA as an adjunct to psychotherapy, rather than as a stand-alone medication. The drug is administered on only 2 or 3 occasions under direct supervision by a psychiatrist and a cotherapist during prolonged psychotherapy sessions, and treatment effects are compared with those of the same therapy without MDMA. The hypothesis that MDMA catalyzes psychotherapy, now being tested with these rigorous study designs, is derived from earlier published reports of the clinical use of MDMA and is consistent with the current understanding of the pharmacology of MDMA.

In 1986, Greer and Tolbert3 published a report on 29 volunteers to whom MDMA had been administered in the presence of a male and a female therapist. The participants reported benefits such as “enhanced self-understanding [and] insight into personal patterns or problems, greater self-confidence or self-acceptance, lowered defenses [while] undergoing a therapeutic emotional process,” and “less negative thoughts or feelings.”

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by James OBrien | June 03, 2011 10:56 AM EDT

I think enough data is in on EMDR. How about a study of MDMA vs. Prazosin?

by Michael Mithoefer | May 28, 2011 10:52 AM EDT

I appreciate the comments of Rodrigo Figueroa and Jennifer Fauntleroy. I think a study comparing EMDR with MDMA-assisted psychotherapy would be worthwhile. Currently, the resources available for clinical trials of MDMA-assisted psychotherapy are directed toward the kinds of study designs that will be necessary for the FDA to consider approving MDMA for clinical use. If larger studies do lead to approval, then studies comparing MDMA-assisted psychotherapy to other methods of therapy will be important and will be easier to do. There is not an ethical problem in our current studies because we enroll only treatment-resistant patients who have failed to respond to previous treatments (in some cases previous EMDR), and if a participant is in therapy at the time of enrollment they may continue that same therapy during the study.
Michael Mithoefer

by Rodrigo Figueroa | May 21, 2011 7:17 PM EDT

And what about head to head EMDR plus MDMA vs EMDR plus placebo? MDMA alone could be against ethical standards, leaving sick people without an evidence-based treatment.

by jennifer fauntleroy | May 19, 2011 2:33 PM EDT

How about a head to head EMDR vs, MDMA?

Also in this Special Report

Introduction: Looking to the Future of Psychopharmacology

Antidrug Vaccines

Novel Treatment Avenues for Bipolar Depression

Does MDMA Have a Role in Clinical Psychiatry?

Ethical Issues in Psychopharmacology






 
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