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Regulation of human research with LSD in the United States (1949-1987).

Katherine R. Bonson

Psychopharmacology February 2018 DOI: 10.1007/s00213-017-4777-4 (opens in new tab)

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AI-extracted from the abstract
Characteristics Historical analysis Peer reviewed
Topics LSD
Keywords Hallucinogen Regulation
Key points Argues that the 1962 Kefauver-Harris Amendments introduced safety and efficacy requirements that 1960s LSD research struggled to satisfy: Albert Kurland's Spring Grove studies largely conformed, while other investigators often fell short of scientific standards and federal requirements. The authors contend these early studies are best understood as pilot data and sources of testable hypotheses for modern hallucinogen research.

Abstract

Human research with hallucinogens such as lysergic acid diethylamide (LSD) has been ongoing in the USA since 1949. During the 1960s, LSD was investigated for a variety of psychiatric indications, including the following: as an aid in treatment of schizophrenia; as a means of creating a "model psychosis"; as a direct antidepressant; and as an adjunct to psychotherapy. Studies with all drugs, including LSD, have always been conducted under federal regulatory controls, including the 1938 Food Drug and Cosmetic Act (FDCA; which ensured the safety of drugs) and the 1962 Kefauver-Harris Amendments to the FDCA (which described appropriate scientific methodology and ensured drug efficacy). This paper details how the 1962 Amendments introduced numerous safety and efficacy requirements that must be in satisfied during clinical drug research-and how human studies conducted with LSD in the 1960s struggled with their fulfillment. Information is provided from Senate hearings, case law, and interviews with key investigators. Examples are also drawn from scientific papers and symposia published during and since that period, with a focus on information from clinical studies conducted with LSD by psychiatrist Albert Kurland at the Spring Grove State Hospital, near Baltimore, MD. While Kurland largely conformed with these new regulations, other investigators often fell short of complying with scientific standards and federal requirements. Thus, the human hallucinogen studies of the 1960s are best understood as providing pilot data on safety and efficacy, as well as testable hypotheses for current hallucinogen studies conducted under modern scientific and regulatory standards.

Comparable studies

Other theoretical and historical papers on LSD, most cited first.

Study Year Design Participants
The Experimental Use of Psychedelic (LSD) Psychotherapy 1970 Historical analysis
LSD: My Problem Child 1981 Historical analysis
On the Use and Abuse of LSD 1968 Theoretical or philosophical paper
The Use of Music in Psychedelic (LSD) Psychotherapy 1972 Theoretical or philosophical paper
Flashbacks: Recurrent Intrusive Images After the Use of LSD 1969 Theoretical or philosophical paper

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