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14 Advances in Psychedelic Medicine Next we present some of the problematic issues and challenges that psychedelics pose to the prevailing psychopharmacological paradigm in modern psychiatry. We conclude with some considerations of the impli- cations of the shamanic traditions and spiritual experiences catalyzed by these substances. Resurrection of Psychedelic Research: Phase 1 Normal Volunteer Studies Considerable psychiatric research was conducted with psychedelics in the 1950s and 1960s. An estimated 40,000 psychiatric patients and research subjects were administered psychedelics during those two dec- ades with more than 1,000 articles published in the professional litera- ture (Grinspoon & Bakalar, 1979). Investigators and clinicians reported impressive treatment responses, particularly with patients with psychiat- ric and addictive disorders resistant to conventional treatment. Unfortu- nately, the political and cultural turmoil of the late 1960s and early 1970s, along with the association of psychedelics with recreational use by young people, led to the eventual banning of this class of drugs for nonmedical and clinical use and suspension of active research programs. From the early 1970s to the early 1990s, almost no human research with psych- edelics was conducted in the United States (Grob, 1998a). Clinical research with psychedelics remained stagnated until Rick Strassman of the University of New Mexico secured federal regulatory approval to carry out a prospective exploration of the effects of DMT (N,N-dimethyltryptamine) on psychological and physiological parameters in healthy normal volunteer human subjects (Strassman, 1996 Strassman, Qualls, Uhlenhuth, & Kellner, 1994a, 1994b). Between 1990 and 1995 Strassman administered several hundred doses of DMT to 60 carefully selected subjects. The approved protocol allowed for exploration of effects even at very high intravenous dosages, up to 1.1 mg/kg, approximately three times the normal psychedelic dose, while maintaining good safety parameters. A result of the DMT project’s success in obtaining permission to conduct human research investigations with Schedule 1 drugs was the subsequent clinical research approvals acquired for two nonclassic psychedelics—MDMA and ibogaine. After receiving approval in 1992, researchers at Harbor-UCLA Medical Center conducted a Phase 1 MDMA (3,4-methylenedioxymethamphetamine) study. While all 18 subjects par- ticipating in the full study reported no psychological or physical distress, two subjects did sustain blood pressure instability at the higher doses, thus emphasizing the need for future MDMA investigators to take a more