Schedule 1 barriers to research in the UK: An in-depth qualitative analysis

Abstract

Background There is increasing research to suggest that certain Schedule 1 drugs, most notably psychedelics, can be effective in treating a range of mental health disorders. However, due to several practical, financial, and bureaucratic barriers, there is a lack of large-scale trials into their efficacy. This study aimed to explore the barriers, and any facilitators, to undertaking Schedule 1 research through examining the different positions Schedule 1 and other controlled drug researchers place themselves in, and the impact this has on their experiences. Method Semi-structured interviews were conducted with 12 participants. Eight Schedule 1 researchers and four researchers who conduct other controlled drug research. Participants were recruited via purposive and snowball sampling. Interview questions explored how participants’ experiences of controlled drug research were impacted by scheduling laws, and how they might differ from the other group. Results Using discourse analysis, four themes were identified. Three themes differentiated the two groups of researchers and their positions ( differential burden of duties, the importance of privileges, and motivations); the differential burden of duties acted as a barrier to non-Schedule 1 researchers, whereas Schedule 1 researchers were better able to deal with this burden due to higher levels of motivation and more privileges (facilitating Schedule 1 research). One theme suggested solidarity between the groups; others acted as barriers to Schedule 1 research, with government officials preventing changes to drug legislation, and those lacking scientific understanding being discriminatory, causing difficulties getting Schedule 1 projects started. Conclusion Findings highlight the challenges that Schedule 1 researchers are currently facing and suggest that the government should commission an urgent review into this by the Advisory Council on the Misuse on the Misuse of Drugs to make Schedule 1 research process smoother and more accessible. For example, reducing the barriers to research of Schedule 1 substances so as to be in line with the regulations controlling those in Schedule 2.

An Interpretative Phenomenological Analysis of the use of psilocybin by veterans with symptoms of trauma

“…Larger studies and clinical trials are required to assess the therapeutic potential of psilocybin for symptoms of trauma and for a range of mental health disorders. Nevertheless, the current study adds to the mounting body of evidence suggesting there is a need to review drug legislation for research and medical purposes (Howard et al, 2021;Nutt et al, 2013).…”

“…This classification assumes that the substance produces harmful effects and has no medical benefit; emerging evidence suggests this may not be correct. The scheduling imposes legal ramifications (such as lengthy prison sentences) for possession of the substance and impedes research (Howard et al, 2021; Nutt et al, 2013). These barriers have resulted in uncertainty surrounding the impact of psilocybin on other mental illnesses, such as PTSD (Nutt et al, 2013; Varker et al, 2021).…”

WHO’s first scientific review of medicinal Cannabis: from global struggle to patient implications

“…], 2017, pp. 385-389), as well as strict scheduling status representing barriers to research at several levels (Campbell, 2015, p. 191;also Cooper et al, 2021, p. 115;Howard et al, 2021;National Academies of Sciences [. .…”

“…Yet, prospective, randomised, double-blind, placebo-controlled clinical trial evidence is limited, in part due to the complex phytochemical formulation of Cannabis derivatives and associated methodological difficulties (National Academies of Sciences […], 2017, pp. 385–389), as well as strict scheduling status representing barriers to research at several levels (Campbell, 2015, p. 191; also Cooper et al , 2021, p. 115; Howard et al , 2021; National Academies of Sciences […], 2017, pp. 378–384).…”

Cost-effectiveness of psilocybin-assisted therapy for severe depression: exploratory findings from a decision analytic model

“…Studies on PAP to date have generally been small and with limited follow-up. The scale of these studies may be limited by the classification of psilocybin as a schedule 1 drug and the associated costs of handling such substances (Howard, Neill, Schlag, & Lennox, 2021; Rucker, 2015). Additionally, PAP sessions are relatively long and staff-intensive, with the average session lasting five hours with two ‘guides’.…”