Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling

Psychedelic drug abuse potential assessment for new drug applications and controlled substance scheduling: A United States perspective

“…Thus, investigators, institutional review boards, and the FDA which reviews studies of Schedule I drugs insist on study approaches that put safety first, and for most clinical studies these do not appear to alter study validity. However, for human abuse potential studies, efforts that include detailed descriptions of the effects that might be experienced, reassurance, and intervention are all intended to influence the resulting experience that helps define the abuse potential of the substances (Belouin and Henningfield, 2018;Griffiths et al, 2006Griffiths et al, , 2008Henningfield et al, 2022;Johnson et al, 2018).…”

“…As discussed elsewhere, safety concerns about high dose administration of hallucinogenic substances has led to considerable caution with respect to dosing, preparations of participants for test sessions, and ensuring that monitors are present at all times to provide reassurance and intervene as appropriate to minimize the risk of severe distress and unsafe behavior (e.g., Belouin and Henningfield, 2018; Henningfield et al, 2022), and recommendations of Johnson et al (2008) appear to be widely followed in all human studies. However, it seems reasonable to propose that several approaches employed to assure the safety of subjects in psychedelic studies have the potential to bias abuse-related findings (Henningfield et al, 2022). For example, pre-study education and preparation include descriptions of the subjective reactions to expect, likely time-course of effects, and how to manage them, including reassurance that the assigned monitor will be continuously present to offer assistance.…”

“…Similarly, in the experience of the authors and as discussed elsewhere, the same general approaches to abuse/dependence potential assessment are relied upon by other regulatory agencies and the World Health Organization Expert Committee on Drug Dependence in evaluations flowing from the international “Single Drug Convention” of 1961 and the “Psychotropic Convention” of 1971 (Belouin and Henningfield, 2018; Heal et al, 2018a; Henningfield et al, 2022; International Narcotics Control Board, 1994; National Academies of Sciences, 2017; Spillane and McAllister, 2003). There are differences across countries and regions, however.…”

“…Thus, although we agree with Bonson (2018) and Calderon et al (2018) that many historical studies of classic psychedelics do not meet today's standards, we also believe that for some of the extensively studied psychedelics, historical data will be sufficient to guide abuse potential related decision making including scheduling and other drug labeling. However, it appears likely that drugs which have not been extensively studied and NCEs will likely require new studies with the amount and type to be determined on a case-by-case basis (Bonson, 2017;Calderon et al, 2018Calderon et al, , 2022Henningfield et al, 2022).…”

Psilocybin for Depression: From Credibility to Feasibility, What’s Missing?

“…Finally, there are clear concerns relating to the toxicological drug test screening (with psychedelics not typically being identified [ 100 ]) in cases of potential abuse/misuse. Overall, it clearly appears that the future of psychopharmacological research should focus on safe practices and inclusive public policies [ 101 , 102 ] without an exasperated emphasis on spirituality.…”