Subject:   Testing Ecstasy on Subjects Diagnosed with PTSD and the Use of Internet Recruiting
Date:   2004-02-02

Additional Information

CIRCARE is concerned about the rights and welfare of 20 men and women soon to be enrolled in a clinical trial testing Ecstasy for the treatment of Post Traumatic Stress Disorder. According to the sponsor, this clinical trial marks the beginning of a multi-year plan to gain FDA approval to market Ecstasy as an anti-depressant medication for the treatment of PTSD.

CIRCARE has serious concerns about testing this drug on vulnerable populations:

1. What is the scientific rationale for giving an hallucinogenic amphetamine to persons diagnosed with PTSD, or in the future, to those with depression? Is the rationale sufficient to justify withdrawing subjects from their current medication?
2. Are there not serious risks in administering an investigational drug like Ecstasy, which can cause rebound depression, neuro-toxicity, and dependency? A recent UN report cites the potential for multiple adverse events including death. Available from http://www.unodc.org/unodc/en/publications/report_ats_2003-09-23_1.html
3. Should high-risk research like this be conducted by a principal investigator with no experience conducting clinical trials, and from his office rather than in the hospital?

The sponsor, the Multidisciplinary Association for Psychedelic Studies (MAPS), states that this research was rejected by seven IRBs before gaining approval. While MAPS claims these rejections were politically motivated, at least two of the IRBs had well-reasoned objections, including:

• The submission of an overly-optimistic safety profile of Ecstasy by MAPS in their Investigator's Brochure, and an inadequate control for bias regarding Ecstasy's therapeutic potential.
• Unclear credentials regarding the persons who wrote the Investigator's Brochure.
• The representation of the study as coming out of the Medical University of South Carolina, and the listing of a faculty member as a co-investigator when there was neither university sponsorship nor IRB approval.

We are also concerned about the MAPS web site:

1. The web site promotes Ecstasy with favorable news articles and testimonials while at the same time recruiting research subjects. This can undermine informed consent, which should be an objective presentation of the potential risks and benefits of research participation.
2. We are particularly concerned by the repeated use of the phrase FDA approved clinical trial of Ecstasy. Strictly speaking, FDA does not approve clinical trials conducted under an Investigational New Drug (IND) application. Rather, the sponsor may begin research if FDA does not object within 30 days of filing the IND application.

In sum, this study raises CIRCARE's concerns about the approval of research which lacks a clear scientific rationale and carries serious risks, the practice of IRB shopping, and the potential abuse of the internet to recruit research subjects.

Elizabeth Woeckner MA, CIRCARE Board of Directors

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327

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Additional Information

Links

Multidisciplinary Association for Psychedelic Studies (MAPS)

Western Institutional Review Board to MAPS, Withdrawal of Approval. 2002-09-06. Available from http://www.maps.org/research/mdma/wirbrescind.pdf

MAPS (sponsor) reply to Western Institutional Review Board (WIRB) Available from http://www.maps.org/research/mdma/wirb11.18.02.pdf

FDA form 1572 submitted by Dr Mithoefer MD, MAPS principal investigator for clinical trial of Ecstasy in subjects diagnosed with PTSD. Available from http://mir.drugtext.org/maps/research/mdma/protocol/form1572.pdf

Dr Michael Mithoefer MD, MAPS Bulletin Vol. 12, No.2. (Description of attempts to submit research to MUSC IRB, Summer 2002). Available from http://maps.org/news-letters/v12n2/12204mit.html

MAPS Research Subject Recruitment. 2003-07. Available from http://web.archive.org/web/20030722141350/http://maps.org/volunteer.html
MAPS Research Subject Recruitment. 2002-08. Available from http://web.archive.org/web/20020803094928/http://www.maps.org/volunteer.html
MAPS Research Subject Recruitment. 2004-02. Available from http://maps.org/volunteer.html

Read Sponsor/IRB Correspondence and More

Correspondence Between IRC-IRB and Sponsor/Investigators

IRC IRB to MAPS. 2003-01-03. Available from http://www.maps.org/research/mdma/irc-maps01.03.03.pdf

MAPS to IRC IRB. 2003-01-20. Available from http://www.maps.org/research/mdma/irc-maps01.20.03.pdf

IRC IRB to MAPS. 2003-02-04. Available from http://www.maps.org/research/mdma/irc-maps02.04.03.pdf

MAPS to IRC IRB. 2003-02-06. Available from http://www.maps.org/research/mdma/maps-irc02.06.03.pdf

MAPS to IRC IRB. 2003-02-10. Available from http://www.maps.org/research/mdma/maps-irc02.10.03.pdf

MAPS to IRC IRB. 2003-02-13. Available from http://www.maps.org/research/mdma/agitmgt02.13.03.pdf

MAPS to IRC IRB. 2003-02-14. Available from http://www.maps.org/research/mdma/ppdbid02.14.03.pdf

Mark Wagner Ph.D., Medical University of South Carolina, MAPS to IRC IRB. 2003-02-07. Available from http://www.maps.org/research/mdma/wagner-irc02.07.03.pdf

Summary of protocol titled Phase II clinical trial testing the safety and efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in the treatment of chronic posttraumatic stress disorder. 2003-01-20. Available from http://www.maps.org/research/mdma/protocolsummary01.20.03.pdf

Michael Mithoefer M.D. Plan for External Evaluation: MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder. 2003-01-20. Available from http://www.maps.org/research/mdma/extevaluation.pdf

IRC IRB to MAPS. 2003-02-21. Available from http://www.maps.org/research/mdma/irc-maps02.21.03.pdf

IRC IRB to MAPS. 2003-03-03. Available from http://www.maps.org/research/mdma/irc-maps03.03.03.pdf

Also of interest

Conditional IRB approval (IRB unnamed). 2003-09-23. Available from http://www.maps.org/mdma/irb.pdf

Research Protocol for study titled Phase II clinical trial testing the safety and efficacy of 3,4- methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in subjects with chronic posttraumatic stress disorder. Study # 63-384. September 24, 2003. Revised January 3, 2005. Available from http://www.maps.org/research/mdma/ptsd_study/protocol/protocol030605.pdf

Index of historical versions of study protocol titled Phase II clinical trial testing the safety and efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in subjects with chronic posttraumatic stress disorder. Available from http://www.maps.org/mdma/protocol/index.html

Informed Consent for study titled Phase II clinical trial testing the safety and efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in subjects with chronic posttraumatic stress disorder. 2003-09-25. Available from http://www.maps.org/mdma/protocol/consent092503.html

Michael Mithoefer M.D. MAPS Bulletin Vol. 13, No.1 (Summer 2003). Available from http://maps.org/news-letters/v13n1/13104mit.html

Full story from MAPS web site. Available from http://www.maps.org/mdma/

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Last Updated: 2007-04-01