Investigation of Psychedelic Effects in Psychoactive Substances
Summary
The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on the subjective effects of 6 different psychoactive substances or inactive placebo. Drug assignment for some sessions will be randomized (like flipping a count or rolling a pair of dice), and both participants and study staff will be blind to the drug condition on any given day. Participants will also complete 2 preparation sessions (4 hours total) before the first experimental session, and follow-up visits after each session to discuss and debrief on the participants subjective experience.
Timeline
- Start
- 2025-02-05
- Primary completion
- 2027-06
- Completion
- 2027-12
Publications
- Background Strassman RJ, Qualls CR, Uhlenhuth EH, Kellner R. Dose-response study of N,N-dimethyltryptamine in humans. II. Subjective effects and preliminary results of a new rating scale. Arch Gen Psychiatry. 1994 Feb;51(2):98-108. doi: 10.1001/archpsyc.1994.03950020022002.
- Background Ko K, Knight G, Rucker JJ, Cleare AJ. Psychedelics, Mystical Experience, and Therapeutic Efficacy: A Systematic Review. Front Psychiatry. 2022 Jul 12;13:917199. doi: 10.3389/fpsyt.2022.917199. eCollection 2022.
- Background Schmid Y, Gasser P, Oehen P, Liechti ME. Acute subjective effects in LSD- and MDMA-assisted psychotherapy. J Psychopharmacol. 2021 Apr;35(4):362-374. doi: 10.1177/0269881120959604. Epub 2020 Oct 8.
- Background Breeksema JJ, Niemeijer A, Kuin B, Veraart J, Vermetten E, Kamphuis J, van den Brink W, Schoevers R. Phenomenology and therapeutic potential of patient experiences during oral esketamine treatment for treatment-resistant depression: an interpretative phenomenological study. Psychopharmacology (Berl). 2023 Jul;240(7):1547-1560. doi: 10.1007/s00213-023-06388-6. Epub 2023 May 24.
- Background Wolinsky D, Barrett FS, Vandrey R. The psychedelic effects of cannabis: A review of the literature. J Psychopharmacol. 2024 Jan;38(1):49-55. doi: 10.1177/02698811231209194. Epub 2023 Nov 10.
- Background Earleywine M, Ueno LF, Mian MN, Altman BR. Cannabis-induced oceanic boundlessness. J Psychopharmacol. 2021 Jul;35(7):841-847. doi: 10.1177/0269881121997099. Epub 2021 Mar 28.
- Background Reissig CJ, Carter LP, Johnson MW, Mintzer MZ, Klinedinst MA, Griffiths RR. High doses of dextromethorphan, an NMDA antagonist, produce effects similar to classic hallucinogens. Psychopharmacology (Berl). 2012 Sep;223(1):1-15. doi: 10.1007/s00213-012-2680-6. Epub 2012 Apr 13.
- Background Carbonaro TM, Johnson MW, Hurwitz E, Griffiths RR. Double-blind comparison of the two hallucinogens psilocybin and dextromethorphan: similarities and differences in subjective experiences. Psychopharmacology (Berl). 2018 Feb;235(2):521-534. doi: 10.1007/s00213-017-4769-4. Epub 2017 Nov 7.
- Background Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177/0269881115609019. Epub 2015 Oct 6.
- Background Barrett FS, Griffiths RR. Classic Hallucinogens and Mystical Experiences: Phenomenology and Neural Correlates. Curr Top Behav Neurosci. 2018;36:393-430. doi: 10.1007/7854_2017_474.
- Background Griffiths RR, Johnson MW, Richards WA, Richards BD, McCann U, Jesse R. Psilocybin occasioned mystical-type experiences: immediate and persisting dose-related effects. Psychopharmacology (Berl). 2011 Dec;218(4):649-65. doi: 10.1007/s00213-011-2358-5. Epub 2011 Jun 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextromethorphan | Unknown | — | Oral |
| Subject | Dimethyltryptamine | Unknown | — | Oral |
| Subject | Dronabinol | Other / unclassified | — | Oral |
| Subject | Ketamine | Small molecule | — | Oral |
| Subject | Midomafetamine | Unknown | — | Oral |
| Comparator | Psilocybin | Other / unclassified | — | Oral |
Indications
No indication recorded.