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Objective: In recent years, there has been a renewed interest in investigating the use of classic psychedelics such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of mental disorders and substance use disorders. However, knowledge about the epidemiology of classic psychedelics in the Nordic countries is limited., Methods: We recruited adult, Norwegian participants who have had a memorable experience after taking a classic psychedelic substance. They filled in an anonymous internet survey with 119 items covering matters related to recreational use of psychedelics using a secure, web-based application. Data are presented by using descriptive statistics (frequencies, means, and standard deviations)., Results: We recruited 841 participants, 770 (72% male; 88% 45 years or younger) of which were included in the data analysis. The intentions behind taking the psychedelic substance were mainly recreational (46.1%) or therapeutic (42.3%). Most participants reported that their most memorable experience was with psilocybin. As in modern era clinical trials, most participants were well-prepared before, did processing during, and did integration work after the experience, whereas only a minority were supported by a therapist. Self-perceived symptoms of various mental disorders and substance use disorders were prevalent in the sample. Most subjects reported improvements in their condition. Although adverse reactions were usually mild and short-lived, 4.2% lasted for 1 year or more. Persisting flashbacks were present for a year or more among 2.9% of the participants., Conclusion: In this cross-sectional sample of Norwegian, self-selecting adults, we shed light on what characterizes the most memorable experience with a classic psychedelic substance, including short- and long-term risks and benefits. For the most part, the psychedelic experience led to improvements in self-perceived symptoms of mental disorders and substance use disorders. However, a small subset experienced persisting adverse reactions., Competing Interests: T-MK received lecture honorarium from Lundbeck. LS and KA were previously employed by Awakn Life Sciences Inc. KA is currently employed at Psykolyse. MU is employed by Somnivore Pty Ltd. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Kvam, Uthaug, Andersen, Refsum, Tunstad, Stewart, Jacobsen and Grønnerød.)

Background: Major depressive disorder (MDD) is a world-leading cause of disability. The available treatments are not effective in all patients, and there is a significant need for more effective treatment options. Here we present the protocol for an investigator-initiated and publicly funded trial of MDMA-assisted therapy (MDMA-AT) for MDD. This single-site, open-label study investigates the proof of principle and safety of MDMA-AT in participants with MDD and provides an initial impression of treatment effectiveness., Methods: A total of 12 participants [>18 years] with DSM-5 diagnosis of MDD will receive a flexible dose of MDMA in a therapeutic setting on two dosing days over a 4 week period preceded by three preparatory sessions. Each MDMA dosing session will be followed by three integration sessions. The primary outcome is change in MDD symptom severity, as measured by the mean change in MADRS scores from Baseline to 8 weeks after the second MDMA session. The secondary outcome is change in functional impairment, as evaluated by the mean change in Sheehan Disability Scale scores from Baseline to 8 weeks after the second MDMA session. Safety measures include vital signs, the incidence of Adverse Events and suicidality as measured by the Colombia-Suicide Severity Rating Scale., Discussion: This proof of principle trial will inform the development of fully powered clinical trials, optimize the protocol for the administration of MDMA-AT in participants with MDD and explore uncertainties including barriers to recruitment, retention and acceptability of MDMA-AT as a treatment for MDD., Clinical Trial Identification: EudraCT number 2021-000805-26., Competing Interests: Author T-MK received lecture honorarium from Lundbeck. Author LS was employed by Awakn Life Sciences Inc. Author OA was a consultant for HealthLytix and has received speaker honorarium from Lundbeck and Sunovion. Author IG was an advisor for Solrise Life Sciences. Several authors are employed at institutions T-MK, IG, LS, and OA at Østfold Hospital; DR at the Charité, which have received research support from MAPS for an MDMA-AT trial for PTSD. Author DR is founding member and honorary Board Chair of MAPS Deutschland, a Germany-based non-profit research and educational organization associated with MAPS. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Kvam, Goksøyr, Stewart, Repantis, Røssberg and Andreassen.)