Human Hallucinogen Research: Guidelines for Safety

By Matthew W. Johnson, William A Richards, Roland R. Griffiths. Journal of Psychopharmacology, 2008

1,051 citations recorded by the source corpus.

There has recently been a renewal of human research with classical hallucinogens (psychedelics). This paper first briefly discusses the unique history of human hallucinogen research, and then reviews the risks of hallucinogen administration and safeguards for minimizing these risks. Although hallucinogens are relatively safe physiologically and are not considered drugs of dependence, their administration involves unique psychological risks. The most likely risk is overwhelming distress during drug action ('bad trip'), which could lead to potentially dangerous behaviour such as leaving the study site. Less common are prolonged psychoses triggered by hallucinogens. Safeguards against these risks include the exclusion of volunteers with personal or family history of psychotic disorders or other severe psychiatric disorders, establishing trust and rapport between session monitors and volunteer before the session, careful volunteer preparation, a safe physical session environment and interpersonal support from at least two study monitors during the session. Investigators should probe for the relatively rare hallucinogen persisting perception disorder in follow-up contact. Persisting adverse reactions are rare when research is conducted along these guidelines. Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science.

Subfields: Cellular and Molecular Neuroscience, Clinical Psychology, Organic Chemistry

View Paper: https://www.semanticscholar.org/paper/554f798f25a69d215bea816211ae014c5319edac

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Citations in the corpus

Psilocybin occasioned mystical-type experiences: Immediate and persisting dose-related effects (2011, background): “The study procedures followed recommendations provided for safe conduct of research administering high doses of a classic hallucinogen (Johnson et al. 2008).”
The entropic brain: a theory of conscious states informed by neuroimaging research with psychedelic drugs (2014, background): “An important caveat however, is that in order for this process to be beneﬁcial, the drug-induced transitions to, and the return from primary consciousness, must be mediated by appropriate therapeutic care (Johnson et al., 2008).”
Mystical Experiences Occasioned by the Hallucinogen Psilocybin Lead to Increases in the Personality Domain of Openness (2011, methodology): “Participants received extensive preparation and met with session monitors for at least 8 h on several different occasions prior to their first drug session, in line with recommendations for hallucinogen research (Johnson et al., 2008).”
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial (2016, background): “It has a well-established physiological and psychological safety profile in human laboratory and clinical trial research (Johnson et al., 2008), is not known to be addictive and may have anti-addictive properties (Bogenschutz and Johnson, 2016; Krebs and Johansen, 2012; Ross, 2012).”
Serotonin and brain function: a tale of two receptors (2017, background): “We also believe that human studies with these compounds can be done safely if appropriate safeguards are heeded (Johnson et al., 2008).”
Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. (2011, background): “A recent review from the psilocybin research group at Johns Hopkins University describes the critical components necessary for ensuring subject safety in hallucinogen research.(36)”
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial (2016, background): “A more detailed description of the study room and procedures followed on session days is provided elsewhere (Griffiths et al., 2006; Johnson et al., 2008).”
The Therapeutic Potential of Psychedelic Drugs: Past, Present, and Future (2017, background): “The traditional view of the mechanism, whereby psilocy- bin works, emphasizes the importance of accompanying psychotherapy (Johnson et al, 2008; Richards, 2015).”
Psychedelics (2016, background): “Anyone contemplating carrying out a clinical research program with a psychedelic is strongly encouraged to read the detailed guidelines presented by Johnson et al. (2008).”
Pilot Study of the 5-HT2AR Agonist Psilocybin in the Treatment of Tobacco Addiction (2014, background): “For each session a physician was on call, and rescue medications were available in case of adverse cardiovascular or psychological events (Johnson et al., 2008).”
Constructing drug effects: A history of set and setting (2017, background): “Leary also suggested that set and setting should be calculated when reporting the results of psychedelic studies by documenting subject and researcher expectations beforehand, an idea that would later reappear in contemporary hallucinogenic research (Johnson et al., 2008).”
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up (2017, background): “Basic principles for safe therapeutic work with psychedelics can be found in guidelines (Johnson et al. 2008) and books (Richards 2015) but more systematic verification, refinement and (eventual) manualisation of treatment approaches are needed for subsequent roll-out (Carhart-Harris and Goodwin…”
Developing Guidelines and Competencies for the Training of Psychedelic Therapists (2017, methodology): “The authoritative compendium of safety procedures for psilocybin-assisted therapy from Johnson et al. (2008) is an oft-referenced summary of the wisdom on safety procedures and ethical practices.”