What taking intravenous ketamine taught me about clinical trial design

Participating in clinical trials can have all sorts of benefits, like getting paid to take intravenous Ketamine (legally). The RELAKS clinical trial is investigating how Ketamine influences learning, particularly learning from reward and punishment. I didn’t need much convincing to sign up. The trial is a double blind randomised control trial, so you actually only have a 50% chance of receiving intravenous Ketamine. You and the investigators aren’t meant to know whether you’ve received the treatment (Ketamine) or Placebo - call it Schrodinger’s Ket. 

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The rest of the Lindus Health team and I participate regularly in clinical trials; we always learn something from the experience that can be fed back into our products. For instance, participating in a Covid Vaccine Phase III study (which Lindus Health didn’t help run) was a great guide for what not to do, as I wrote about here. The RELAKS trial was complex, involving multiple in-person visits, but showed how good organisation and clear communication can make participation easy and painless, leading to higher quality data and faster trial execution for trial sponsors! And it felt great to contribute to ground breaking research about a promising treatment for numerous mental health conditions like depression and suicidal ideation. 

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After a fairly straightforward screening call, I was accepted to the study. Most of the screening questions and initial assessments consisted of validated questionnaires. These are short questionnaires designed to measure or diagnose conditions like depression (e.g. PHQ-9), Anxiety (e.g. GAD-7) and emotion and cognition. You’d be surprised at how important these seemingly simple questionnaires are during clinical studies in mental health indications, and how new treatments are approved on the basis of responses to these questionnaires. 

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Back to the RELAKS study; I arrived for my dosing visit at the Warneford Hospital in Oxford. After some initial assessments, I was taken to the dosing room, and hooked up to my mystery placebo/ketamine infusion, accompanied by several of the trial team. I know what you’re thinking, is this about to turn into some kind of Vice/Erowid forum trip report? Sadly I can’t reveal whether I had the placebo or ketamine as I don’t want to unblind the investigators, even though I’m pretty sure it will have been obvious to those with me in the room which substance I received! I’m told some participants demanded that music be played, felt the bounds of time and space dissolve or insisted the (plain beige) walls were pulsing with fractals of primary colours. 

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One of the quirks of psychedelic clinical studies is that it is very hard to keep investigators and participants blinded to whether a participant has had the treatment (a psychoactive substance like Ketamine or Psilocybin) or the placebo (a non psychoactive substance like saline). Your senses can deceive you, sure, but when you take these compounds, particularly intravenously, it’s hard to hide. This has implications for the scientific validity of these studies, as double blinding helps control for the placebo effect and avoids investigator bias. Simple steps like having different investigators provide dosing and review data (which RELAKS employed) can help mitigate, as can other initiatives like using synthetic control groups. 

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The next day, I returned for my second visit, which involved playing a series of memory games in an MRI machine! The goal is to compare performance of participants who received Ketamine with those who did not, to investigate how Ketamine affects memory and learning in the medium term. Given the promise of Ketamine as a treatment for very common conditions like depression, frequent use as a treatment in the US, and the frankly widespread recreational use, this is an important research question!

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A final visit the following week for more assessments completed my participation in the study. I was £400 richer, brain tumour free (clinical trial investigators are obliged to inform participants of any medically significant symptoms, features or diagnoses uncovered during the trial) and happy to have contributed to an important research question.  

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This was a complicated study, involving multiple participant visits, numerous assessments and administration of a controlled substance. However, the participant journey was smooth. I had a single point of contact (thanks Pilar!), so it was always clear who I could contact if I had any questions. All communication from the study team included clear next steps, what I needed to do, where I needed to be and when. We've adopted these best practices at Lindus Health; all our trial participants are looked after by a dedicated member of the trial team who guides them from recruitment to consenting and enrolment, and all email or text communication comes from this person. We provide reminders for upcoming appointments, FAQs to refer back to, but otherwise try to refrain from overloading participants with information. 

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So whether you’re a fan of intravenous drugs, MRI machines or advancing research, take part in a clinical trial. You’ll always learn something, even if you get the placebo. The RELAKS study is still recruiting - you can sign up here! 

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Disclosure: Lindus Health helped recruit and screen participants for the RELAKS study. 

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