Good, Meghan http://orcid.org/0000-0002-3829-0723
Joel, Zelah
Benway, Tiffanie
Routledge, Carol
Timmermann, Chris
Erritzoe, David
Weaver, Richard
Allen, Graham
Hughes, Charlotte
Topping, Helen
Bowman, Amy
James, Ellen
Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetics of N,N-dimethyltryptamine in Humans
https://doi.org/10.1007/s13318-023-00822-y
Article History
Accepted: 22 February 2023
First Online: 22 April 2023
Declarations
:
: M.G., T.B., Z.J., C.R. and E.J. are all currently paid employees of Small Pharma and have owned stock in the company, C.T., D.E., G.A., R.W., C.H., H.T. and A.B., are all paid employees of contracted research and academic organisations or independent consultants engaged by Small Pharma.
: This study was funded by Small Pharma. Editorial support was provided by Michelle Preston and Karen Palmer of Livewire Editorial Communications, which was funded by Small Pharma<b>.</b>
: The trial proposal and any substantial amendments were reviewed by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the London—Brent Research Ethics Committee (REC). The trial was not started until a clinical trial authorisation had been obtained from the MHRA, and written approval had been obtained from the REC. The Phase 1 trial was done at HMR in accordance with their standard operating procedures (SOPs); The Medicines for Human Use (Clinical Trials) Regulations 2004 and The Human Medicines Regulations 2012, with current amendments; Good Manufacturing Practice (GMP); the SOPs issued by the Research Ethics Service for RECs in the UK; and Good Clinical Practice (GCP), which has its origins in the Declaration of Helsinki. All data generated during the trial are archived at HMR and will be stored for at least 25 years.
: The datasets generated during and/or analysed during the current study are filed in EudraCT and are not publicly available (in accordance with the regulations for phase 1 data). Further information is available from the corresponding author on reasonable request.
: Not applicable.
: All participants gave written consent to participate in this trial. Before giving consent, participants read the information about the trial. They then discussed the trial with the investigator or their delegate and were given the opportunity to ask questions. The trial specific information sheet and the consent form were approved by the REC. Each subject was free to withdraw from the trial at any time, without giving a reason. Consent for coronavirus disease 2019 (COVID-19) testing was taken using a special information and consent form (ICF), which was approved by the Health Research Authority (HRA) Generic Documents Review Committee.
: Not applicable
: EJ, ZJ, TB, CR, DE and CT made substantial contributions to the conception or design of the clinical trial. MG, EJ, GA, ZJ, TB, CR, CH, HT and AB made substantial contributions to analysis and interpretation of clinical trial data. MG, ZJ, EJ, TB, CR, RW and AB made substantial contributions to the design, analysis, and interpretation of preclinical study data. Drafting, revision and approval of the article was led by MG, EJ and CR.