Ecstasy Approved for Medical StudyCNN, Wed Feb 25 2004
Corrections and comments

by Ilsa Jerome PhD and Rick Doblin PhD

It is heartening to see the MDMA/PTSD study garner such balanced coverage, including direct quotes from the principal investigator. However, the report contains some significant inaccuracies concerning the study design that need correcting. Following each quote from the report are corrections and comments.

1. "Dr. Michael Mithoefer plans to conduct psychotherapy sessions with 20 women who suffer from post-traumatic stress disorder due to sexual assaults or other violence, and who haven't been helped by other treatment."

   The US study will enroll both men and women, and is not restricted to female volunteers. Perhaps the reporters are confusing the US study with research begun in Spain that enrolled women who developed PTSD after sexual assault. Unfortunately, the Spanish study was halted for political reasons.

2. "Psychiatrists quickly became aware of its unusual properties, and several dozen experimented by giving MDMA to patients -- including people suffering post-traumatic stress disorder -- and others with intense anxiety after receiving diagnoses of terminal cancer."

   Psychiatrists recorded anecdotal accounts of using MDMA-assisted therapy in people with various disorders, including PTSD. Researchers in Europe and the US have conducted experimental studies of the effects of MDMA in healthy humans. By contrast, this study Dr. Mithoefer will be conducting is an experimental study of MDMA-assisted psychotherapy in people with PTSD."

3. "There's no real placebo," [study critic Dr. Lillienfeld] said. "Everyone will know who's on the drugs. What I wonder is, instead of a placebo, why aren't they giving a drug that mimics the physical effects?"

   We are using an inactive placebo in this pilot study which is being conducted primarily to assess safety and to help us develop our treatment approach. There will be a time for active placebos in subsequent trials but the best approach to produce a genuine double-blind is to use low dose MDMA in a dose-response design rather than a drug such as methamphetamine that has somewhat similar physical effects but quite distinct psychological effects.

   While it is true that the principal investigator and the subjects are going to have a basis for guessing what condition they are assigned to, it is not true that "everyone" will know the difference. The person performing the psychological assessments for the study will not be present during either of the experimental sessions and will not be able to view data gathered from these sessions. Since the study will rely on the measures taken by this consultant, the outcome measures should be less affected by expectancies than it might appear.

4. "Patients in this clinical trial will be given the drug only one or two times. They will be under a doctor's supervision for the entire time they are under the drug's influence."

   Study volunteers will receive exactly two doses of 125 mg MDMA or placebo on two separate occasions spaced three to five weeks apart.