In the spring of 1991 the Food and Drug Administration's Pilot Drug Evaluation Program approved a study protocol submitted by Albert A. Kurland, M.D., Richard Yensen, Ph.D., and Donna Dryer, M.D. called, "The Relationship between Peak Experience and Outcome in LSD Assisted Psychotherapy with Substance Abusers, A Double-Blind Controlled Study". This protocol was an addendum to an Investigational New Drug permit that had been active since the early 60's under the administration of Albert A. Kurland, M.D.
Dr. Kurland was the first director of the Maryland Psychiatric Research Center (MPRC). The center was a multi-million dollar facility where the Clinical Science Division's mission was to study psychedelic drugs as adjuncts to psychotherapy. This research took place at the MPRC from 1968 to 1976 when, through a series of unfortunate political episodes, the Maryland state government decided to stop psychedelic research.
Richard Yensen was a research fellow at the MPRC from 1972 to 1976. He studied psychedelic psychotherapy with Stanislav Grof, M.D. and other senior staff. During this time he treated patients with substance abuse disorders, cancer, neurosis, and other health professionals seeking a training experience. Dr. Yensen did his Ph.D. dissertation on the use of MDA in psychotherapy with neurotic outpatients and conducted his research at the MPRC.
When the research center was closed in 1976, Dr. Yensen and Dr. Kurland began discussions regarding how to continue the LSD research. In 1985, Dr. Yensen met Dr. Dryer and began a collaboration based on a mutual interest in shamanism. After forming a non-profit corporation, the Orenda Institute, they decided to carry the LSD research forward The Institute's mission is to research, develop and support responsible clinical applications of altered states of consciousness and psychotherapy.
In 1990, Drs. Kurland, Yensen, and Dryer submitted a protocol to the FDA for LSD assisted psychotherapy in the treatment of patients with a substance abuse disorder (DSM III-R). The research objectives and hypotheses of this study are:
1) to determine the relationship between the occurrence of a peak experience, as an objectively measured event in LSD assisted psychotherapy, the number of exposures to LSD during psychotherapy, and clinical improvement as reflected in objective measures of therapeutic outcome. This outcome would be demonstrated by a statistically greater and/or more sustained improvement in the subjects having peak experiences as measured by both therapist evaluation and objective measure (Peak Experience Profile). At the end of therapy and throughout the follow-up period of one year the subjects with peak experiences would demonstrate less substance abuse (by weekly urine drug screens and other objective measures), report fewer psychiatric symptoms and demonstrate less psychopathology than the subjects without peak experience(s). The peak experience group would exhibit more stable personality characteristics, greater positive value orientation and superior social adjustment as compared to the non- peak experience group.
2) the secondary hypothesis of this double-blind, controlled investigation is that LSD, in our psychotherapy environment, will demonstrate a dose response effect yielding statistically significant differential response to treatment. This outcome would be demonstrated by a statistically greater and/or more sustained improvement in the subjects receiving higher dosages of LSD. At the end of therapy and throughout the follow-up period of one year the higher dose LSD subjects would demonstrate less substance abuse (by weekly urine drug screens), report fewer psychiatric symptoms and demonstrate less psychopathology than the lower dose subjects. The higher dose LSD groups would exhibit more stable personality characteristics, greater positive value orientation and superior social adjustment as compared to the lower dose groups.
There are more than a thousand clinical papers (discussing over 40,000 patients), several dozen books, and six international conferences on the use of LSD in psychotherapy. Impressive claims have been made for LSD in the treatment of alcoholism and substance abuse, however, few studies have satisfied stringent methodological design. This study is a methodologically sound effort to evaluate efficacy using effective controls, objective measures of change, and an adequate period of follow-up. This approach addresses all of the deficiencies noted in earlier studies.
This study also assesses the impact of a range of LSD dosage. This exploration of short-term intensive outpatient LSD therapy for substance abusers attempts to isolate significant factors (dose of LSD, occurrence of a peak experience) in the overall treatment process. The analysis of results should yield valuable information about predictive factors for positive outcome. This would allow accurate selection of patients likely to respond positively in future studies or treatment. The effective elements in this therapy could then be combined, with this selection criteria, into a superior treatment for substance abuse; one that provides the despairing substance abuser with an effective treatment for the loss of meaning at the core of any addiction.
The next step toward actually doing the study is to have it approved by an Institutional Review Board (IRB), an administrative committee that most universities and hospitals have in order to review the safety and ethics of doing research with human subjects. As soon as we find an IRB and have the study approved then we can begin the practical work of securing funding and conducting the study.
The protocol as approved by the FDA allows the administration of LSD to sixty people who are randomly assigned to three groups. Each group receives a different dose of LSD, either 100 g, 200 g, or 400 g for up to 5 sessions. Each person entering the study will receive a comprehensive battery of psychological tests and up to twenty hours of preparatory psychotherapy. Then they will have an all day LSD session followed by at least five hours of psychotherapy over two weeks before they may have another LSD session. The decision to give them another session and the timing of that session is based on the experience of the person during the session and their ability to integrate the peak experience into their life. There are many ways we will use to evaluate this including the team's clinical judgment, more psychological tests, the person's own report and that of their significant others, and urine screens.
If we secure IRB approval and receive even modest funding, we will begin this process with a just a few patients. For example, with five thousand dollars, we could complete the first twenty hours and one LSD session with three people. Practically, this would also give us the ability to apply for more money to begin to train a few other therapists to work with us. Of course, completing the work with the first few people would be given priority before we would start with any more. Our offices and therapy practices are set up in such a way that we could continue at this "few people at a time" rate or increase the flow as funds become available.
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