Jerome Beck, Dr. P.H.

March 12, 1992

By virtue of its placement in Schedule 1 of the Controlled Substances Act, MDMA is deemed to possess a high potential for abuse. Indeed, a number of animal studies have found similarities in self-injection behaviors between MDMA and commonly abused stimulants such as amphetamine (Glennon and Young, 1984; Lamb and Griffiths, 1987; Sannerud, Brady and Griffiths, 1989).

However, despite the above animal data, there remains little evidence of problematic consequences associated with MDMA abuse in humans. Reviews of problem indicators have revealed only infrequent reports of hospitalizations, deaths, arrests, or treatment admissions related to MDMA use ( Beck,1990; Dowling, 1990; Korf, Blanker and Nabben, 1991; Newmeyer, 1986). Lacking any valid estimates of use, this quiescence can be interpreted in a number of ways. After reviewing the available data, Dowling (1990) concurs with a previous epidemiological assessment made by Newmeyer (1986) in noting that "although minor side effects produced by MDMA are quite common, serious toxic reactions are exceptionally rare" (1990:67). Dowling goes on to conclude that "human deaths that can be attributed to MDMA or MDEA (MDE) appear to be exceedingly rare, especially when one considers the widespread use of these drugs in the United States" (Dowling, 1990: 74).

Based on their findings of what remains the only NIDA-funded sociological study of MDMA users, the researchers concluded that MDMA's low to moderate abuse potential was a significant factor accounting for the minimal problems associated with its use (Beck, et al., 1989). As such, their findings concurred with those of the DEA administrative law judge following hearings conducted to resolve the MDMA scheduling controversy (Young, 1986).

Four other studies of nonmedical MDMA use, two in the United States and one each in the Netherlands and Australia, provide additional evidence suggestive of a relatively low abuse potential (Korf, Blanken and Nabben,1991; Peroutka, 1990; Siegel, 1986; Solowij and Lee, 1991). In the Netherlands, investigators determined that MDMA results in a low level of abuse and concluded that MDMA "is mainly used with moderate frequency and most users apply regulation mechanisms. Seldom do we see the use of ecstasy become increasingly intensive" (Korf, Blanken and Nabben, 1991: 142). In testimony submitted on the DEA's behalf at the administrative hearings, Siegel concluded from his exploratory study that : "Compulsive patterns marked by escalating dose and frequency of use have not been reported with MDMA users" (1985:2-3). From his survey of Stanford undergraduate users, Peroutka arrived at essentially the same conclusion in finding that "there are simply no reports on individuals who take frequent and large amounts of MDMA for an extended period of time" (1990: xii).

All of the above studies found that very frequent and/or binge use of MDMA typically produces a strong dysphoric reaction which is only exacerbated by continued use. Users often described how increasingly unpleasant aftereffects occurred with greater rapidity and intensity with MDMA than other more commonly abused substances such as cocaine.

In addition to the above findings, any concerns regarding potential nonmedical use or abuse arising from this study are further lessened by the nature of the proposed research and the intended target population. Although the NIDA-funded "Exploring Ecstasy" study was able to locate a small number of MDMA users who had engaged in frequent and/or binge use of MDMA, they were typically recreational enthusiasts possessing extensive experience with cocaine and other drugs. Reports of abuse were particularly uncommon among those respondents who employed MDMA for more therapeutic or spiritual purposes (Beck, et al. 1989)

These findings are supported by a survey of 17 psychiatrists and 3 clinical psychologists who have used MDMA extensively as a therapeutic adjunct for a wide variety of conditions

(Harlow and Beck, 1990). The sample consisted of 15 therapists in the United States who employed MDMA before it's scheduling and 5 psychiatrists in Switzerland who are currently permitted by the government there to use MDMA in therapy. Together, the 20 therapists have administered MDMA in over 8000 sessions. Based on their experience, all felt that MDMA possessed only minimal potential for abuse, particularly when given in a therapeutic context. Only two knew of patients who had actively sought out MDMA after being introduced to it in therapy. Neither of the patients were believed to have engaged in a subsequent abusive pattern with MDMA. In general, the therapists believed that the vast majority of patients were satisfied with the small number of MDMA sessions (typically only 1-4 experiences) they received.

Among the contributory factors accounting for this non-therapeutic disinterest in MDMA among patients are the significantly different motivations and expectations accompanying the use of MDMA as a therapeutic adjunct (Watson and Beck, 1991). As such, factors related to set, setting and therapeutic intentions appear to further reduce potential abuse. The frequently cited euphoric feelings associated with recreational use are often remarkably absent in patients working through severe emotional problems. As exemplified at the DEA administrative hearings, rape and other trauma victims were often angered and/or perplexed at MDMA being referred to as "Ecstasy" and employed for hedonistic pursuits (Harlow and Beck, 1990).

Beck, J, Harlow, D, McDonnell, D, Morgan, P, Rosenbaum, M and Watson, L: Exploring Ecstasy: A Description of MDMA Users. Final NIDA Report, Grant #1 RO1 DA04408. 1989.

Beck, J: The Public Health Implications of MDMA Use. In SJ Peroutka (Ed.), Ecstasy: The Clinical Pharmacological and Neurotoxicological Effects of the Drug MDMA.Norwell, MA: Kluwer Academic Publishers, 1990.

Dowling, GP: Human Deaths and Toxic Reactions Attributed to MDMA and MDEA. In SJ Peroutka (Ed.), Ecstasy: The Clinical Pharmacological and Neurotoxicological Effects of the Drug MDMA. Norwell, MA: Kluwer Academic Publishers, 1990.

Glennon, RA, and Young, R: Further investigations of the discriminative stimulas properties of MDA, Pharmacol Biochem Behav 20:501-504, 1984a.

Harlow, D and Beck, J: Survey of the clinical use of MDMA. Presented at MAPS International Conference on Psycholytic Psychotherapy, Bern, Switzerland, Nov. 29, 1990.

Korf, D, Blanken, P, Nabben, T: Een nieuwe wonderpil? Amsterdam, 1991.

Lamb, RJ, and Griffiths, RR Self-injection of d,1-3,4-methylenedioxymethamphetamine (MDMA) in the baboon. Psychopharmacology 91:268-272, 1987.

Newmeyer, JA: Some Considerations on the Prevalence of MDMA Use. J. of Psychoactive Drugs 18(4): 361-362, 1986.

Peroutka, SJ: Preface. In SJ Peroutka (Ed.), Ecstasy: The Clinical Pharmacological and Neurotoxicological Effects of the Drug MDMA. Norwell, MA: Kluwer Academic Publishers, 1990.

Peroutka, SJ: The Recreational Use of MDMA. In SJ Peroutka (Ed.), Ecstasy: The Clinical Pharmacological and Neurotoxicological Effects of the Drug MDMA. Norwell, MA: Kluwer Academic Publishers, 1990.

Sannerud, CA, Brady, JV, and Griffiths, RR: Self-injection in Baboons of Amphetamines and Related Designer Drugs. In Asghar, K. and Desouza, F. (Eds.), Pharmacology and Toxicology of Amphetamines and Related Designer Drugs - NIDA Research Monograph #94, 30-42, 1989.

Siegel, RK: MDMA: Nonmedical Use and Intoxication.J. of Psychoactive Drugs 18: 349- 354, 1986.

Solowij, N and Lee, N: Survey of Ecstasy (MDMA) Users in Sydney. New South Wales Health Department Research Grant Report Series DAD 91-69, Rozelle, NSW. 1991.

Watson, L and Beck, J: New Age Seekers: MDMA Use as an Adjunct to Spiritual Pursuit. J. of Psychoactive Drugs 23(3): 261-270. 1991.

Young, FL: Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge. Submitted in the Matter of MDMA Scheduling, Docket No. 84-88, May 22,1986.

The sponsor/investigator of this protocol, Dr. Charles Grob, has permission to reference the material in the FDA Drug Master File # 6293, held by the Multidisciplinary Association for Psychedelic Studies, Inc. (MAPS). This material includes a 28-day MDMA toxicity study in the dog and the rat as well as information about the composition, manufacturing and control of the drug substance to be used in this IND, manufactured by Dr. David Nichols of Purdue University.

____________________________ _________________

Richard Doblin, President of MAPS Date

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