This community is a place to share information and support with others who are trying to stop using drugs, prescription drugs, alcohol, tobacco or other addictive substances. Discuss with others, the symptoms of addiction, addiction recovery, ways to quit like tapering and cold turkey, and withdrawal symptoms. If you are interested in general "chat", please visit our
Addiction Social Community.
Kova
Kova
Kova
Kova
A research team under the director of Dr. Michael Mithoefer has worked with MAPS to design and obtain FDA-approval to conduct an MDMA/PTSD pilot study in the United States. The protocol was approved by the FDA on November 2, 2001. As of May 2002 , the protocol is still in the midst of the IRB approval process. The study should begin Summer 2002. The protocol will involve 20 subjects with PTSD, both male and female. All 20 subjects will receive about 12 hours of non-drug psychotherapy. Twelve subjects will also receive two sessions of MDMA-assisted psychotherapy scheduled three to five weeks apart, with a dose of 125 mgs at each session, while 8 subjects will receive 2 placebo sessions. The goals of this study are 1) to evaluate whether MDMA can be safely administered to PTSD patients and 2) to determine whether there is any preliminary evidence of therapeutic efficacy and, if so, to develop an estimate of the effect size.
The entire treatment course will be conducted in 12 weeks or less, in accordance with the recommendations made in the FDA Pharmacologic Drugs Advisory Committee meeting that reviewed the data from the trials of Zoloft in the treatment of PTSD,
If the study does begin in Summer 2002, the research team should be able to complete both sessions in all 20 patients by Summer 2003. The analysis of initial data can be completed by Fall 2003, with six month follow-up data analysis completed by Winter 2003. The final report can be completed by Spring 2004.
The cost of the study is estimated to be $12,000 per subject or $240,000. The costs of this study include non-drug psychotherapy hours as well as thorough neuropsychological evaluations, and quite a substantial cost for administrative work on the FDA and IRB approval process. Subsequent studies will probably require fewer non-drug psychotherapy hours and may not require any neuropsychological evaluations, depending on the results from this initial pilot study. Since administrative costs have been averaged over a small number of subjects, subsequent studies with much larger subject populations, at least 10 times the size of this pilot study, can be conducted with significantly less cost per patient.
if you know about long term damage to the brain from this drug, why are you asking this question?
i gotta go now, but nice debating with you. i always learn something on this forum.
love and light to you,
Kova
maybe you should try the addiction community forum. this one is more for people who are trying to cope with drug withdrawals, so naturally you will get a lot of strong reactions. maybe you learned something from that as well?
peace,
Kova