Trials Update

This page explains the process we take to digest new psychedelic trials. This process is divided into two parts: selection and adding information.

0. You can login here.

  • with your UserName or email and password as provided by Floris

2. Adding Information

2.1 New Trial

  1. Go to Trials -> All Trials
    • (explanation) this is the back-end of the WordPress environment
  2. Select ‘Drafts‘ OR make a new trial entry (‘Add New’)
    • you can go here directly (skipping step 1)
  3. Open the top draft by clicking on the title
    • you can also click on ‘edit’, this does the exact same thing
    • only open a draft that has no ‘tags’, or the tag ‘stopped here’
    • if the post has the tag ‘to review’, you have already finished this one
  4. You are now on the individual ‘trial’ page, here you will start filling in information
  5. Open a new browser/tab and go to the ‘Trial URL’ link
    • you can find the link by scrolling down a bit
    • if this link is not there, search for the title of the trial on Google
  6. From that page, copy the description that best captures the study, paste this in ‘Trial Description’
    • On clinicaltrials.gov (CTG) this usually is the ‘brief summary’
    • if the brief summary is just one line of text, please copy something from the detailed description
  7. Now select the ‘Status’ of the study, this is currently being shown above the title of the study on CTG
  8. The ‘Results Published’ is always, ‘No’ unless I’ve pre-selected it as ‘Yes’ (e.g. for an old trial we’re adding)
  9. The ‘Start Date’ is the Study Start (Estimated) shown on the right side of the screen
  10. The ‘End Date’ is the Study Completion (Estimated) shown in two rows below (i.e. ignore the Primary Completion date)
  11. The ‘Study Design’ can be found under Study Plan (halfway down the page) and then under How is the study designed?
    • this is often ‘Open’ (everyone knows who is getting what) and for some trials ‘Blinded’ (double-blind, single-blind, etc)
    • you may also see this mentioned in the short description or title, if so you don’t have to check here
  12. The ‘Study Type’ is 99% of the time ‘Interventional’, this just means they did something actively versus observing a population (i.e. feel free to ignore this one)
  13. The ‘Enrollment’ is the total number of participants, this can be found right next to the dates
  14. The ‘Min/Max Age’ and ‘Sex’ can be found under Participation Criteria (just above the Study Plan)
  15. The ‘Generation’ refers to the type of drug that is being tested, this is usually ‘First’
    • First refers to existing molecules like psilocybin, MDMA, LSD, etc
    • Second refers to novel formulations like COMP360
    • 95% of the time it’s first and in doubt select this
  16. The ‘Therapy’ selector indicates if the trial incorporated a therapeutic component
    • This is usually the case for psychedelics like psilocybin and MDMA
    • This is usually not the case for ketamine
  17. The ‘NCT Number’ refers to the number/indicator that the trial has gotten (on CTG or somewhere else)
    • This can be found at the top, just below the title and when copying it over, include the NCT, eg. ‘NCT06005662’
  18. For ‘From CTG’ please select ‘Yes’ if it’s from Clinical Trials . Gov, otherwise keep ‘No’ selected
  19. For ‘Change of trial happening/success’ please leave empty (I might remove these later, but not actively being used)
  20. For ‘Funded by’ please select which you think fits best, this is a ‘University’ in most cases (e.g. Johns Hopkins University)
    • You can find the sponsor at the top, right below the CTG number
    • Or find more information under Collaborators and Investigators
  21. For the ‘Phase’ please select the one (or two) that are mentioned in the study, this can be found right below the Study Type
    • use ‘ctrl+click’ to select multiple (e.g. Phase I + Phase II if that is indicated in the trial)
  22. PFF, that was quite a bit, but now we have all the basic information filled in, let’s move on to the relational sections
  23. Compound: select to compound(s) which was studied (type the first 3 letters to start the search – this also applies to the next few actions)
    • use ‘+ add more’ to add more compounds
    • if it’s a second generation compound (e.g. COMP360) and it clearly states what it’s based on (psilocybin) then select that compound
  24. Condition: select condition(s) which are being studied, select ‘Healthy Subjects’ if it’s a study in healthy subjects (usually Phase I)
    • if it’s a specific condition that fall under a larger category, select both (e.g. Opioid Use Disorder + Addiction, or Bipolar + Depression)
  25. Sponsor/Collaborator: select the sponsor of the study
    • if you can’t find the company/university, leave blank (then Floris still needs to make a company page for it)
  26. Country: where is the trial taking place, this is usually the United States
    • if multiple countries, select the first/main country
  27. Measures: ignore for now
  28. Papers: ignore for now
  29. Also ignore the rest that is below there (Posts, Page, Videos, News)
  30. ALRIGHT, now we’re moving into the final part of adding a new trial – the description of the study & final meta-data
  31. To make the description, please use the prompt that I’ve sent you via Upwork
  32. Then copy that to the main text of the post
    • Add enters (to make more paragraphs) where necessary
  33. Then copy the first sentence to the ‘excerpt’ (on the right side)
  34. Add the tag ‘month YYYY’ (e.g. january 2024)
  35. Add the tag ‘to review’
  36. Add the sidebar, right sidebar, ‘Trials Sidebar’
  37. Then click ‘Save Draft’ on the top right

If you are finished with a trial, you can start again at the start of this sequence.

2.2 Updating Trial

Many of the old trials are missing the extensive description, and possibly other data. The goal of this task is to go through the old trials and add the missing information. This time we’re starting the other way around, first doing the description and then checking/adding the rest.

  1. Go to Trials -> All Trials
  2. Go to the last page, or the page where you left off (i.e. all trials without the tags ‘full review’ or ‘to review’
  3. Open the trial by clicking on the title
  4. You are now on the individual ‘trial’ page, here you will start filling in information
  5. Open a new browser/tab and go to the ‘Trial URL’ link
    • you can find the link by scrolling down a bit
    • if this link is not there, search for the title of the trial on Google
  6. To make the description, please use the prompt that I’ve sent you via Upwork
  7. Then copy that to the main text of the post
  8. Then copy the first sentence to the ‘excerpt’ (on the right side)
  9. Add the tag ‘month YYYY’ (e.g. january 2024) (remove the old one if it was there)
  10. Add the tag ‘to review’
  11. Then I’m going to be a bit more vague here, as I don’t know exactly what information is missing, here are a few key points:
    • Check if the drug (relationship) is filled in
    • Check if the condition is selected (and if multiple are selected if it’s a subcategory)
  12. Then click ‘Update’ on the top right

1. Selection

1.1 Clinical Trials . Gov

  1. Go to clinicaltrials.gov and use the following search (in: ‘other terms’): psychedelic OR psilocybin OR ketamine OR mescaline OR peyote OR ayahuasca OR MDMA OR ibogaine OR kratom OR 2c-b OR salvia divinorum
    • Note: don’t search for DMT (you will find it by searching for ayahuasca) as this is an abbreviation used for (many) other things
  2. Then add the criteria ‘first posted’ to the last date we updated the trials (e.g. 30/01/2024)
  3. Then double-check the trials for relevancy (e.g. if they are looking at mental health vs anaesthesia for ketamine studies) and add the relevant trials (see above)

1.2 Oceania

  1. Search the Australia & New Zealand trial registry (ANZCTR)
    • https://www.anzctr.org.au/
    • Use this query (it’s limited to 100 characters): psychedelic OR psilocybin OR ketamine OR mescaline OR peyote OR ayahuasca OR MDMA OR ibogaine
  2. Then, under registration date: add the date since we last searched through the trials

1.3 Europe

  1. Search on the EU Clinical Trials Registry with the following search term
    • https://www.clinicaltrialsregister.eu/ctr-search/search?query=psilocybin+OR+psychedelic+OR+MDMA+OR+ibogaine+OR+peyote+OR+ayahuasca+OR+ketamine
      • psilocybin OR psychedelic OR MDMA OR ibogaine OR peyote OR ayahuasca OR ketamine
    • Then under advance, choose the date since the last search, e.g. https://www.clinicaltrialsregister.eu/ctr-search/search?query=psilocybin+OR+psychedelic+OR+MDMA+OR+ibogaine+OR+peyote+OR+ayahuasca+OR+ketamine&dateFrom=2024-02-01
    • Note: UK trials are captured under the ISRCTN registry
  2. (German & Dutch trial registry should be in the EU database, just noting here for completion)
    • also, names of trials in these databases are often different
    • https://drks.de/search/en
    • https://www.onderzoekmetmensen.nl/en/search
  3. psilocybin, LSD psychedelic, MDMA, ayahuasca, ibogaine, 2c-b, kratom, salvia divinorum

1.4 Other

  1. Search the ISRCTN registry (international) with the following search term
    • https://www.isrctn.com/search?q=psilocybin+OR+psychedelic+OR+MDMA+OR+ibogaine+OR+peyote+OR+ayahuasca+OR+ketamine
    • Note: this automatically sorts by date (newest at the top)
    • Note: I’m not sure about duplication between this and the EU registry, but it now looks like there is only a bit of overlap, but some with clinicaltrials.gov (alas, but then you can see below under ‘additional identifiers’ that an NCT number is filled in (so quickly search for that to find the title in CT.G (which is different)), if it exists already, don’t add it
  2. Search the UK registry (NIHR)
    • https://bepartofresearch.nihr.ac.uk/
    • search for keywords (e.g. psilocybin) one at a time

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