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Risk of bias in randomized clinical trials on psychedelic medicine: A systematic review.

Oliver Rumle HovmandEmil Deleuran PoulsenSidse ArnfredOle Jakob Storebø
Published in: Journal of psychopharmacology (Oxford, England) (2023)
Successful blinding of intervention is a significant challenge in this field. To better accommodate this, we suggest that future trials use a parallel-group design and utilize an active placebo on a psychedelic-naïve population. Future trials should publish trial protocol and SAPs, use clinician-rated outcomes accessed by a blinded rater, evaluate blinding of intervention, and consider measuring expectancy and therapeutic fidelity.
Keyphrases
  • randomized controlled trial
  • study protocol
  • current status
  • phase iii
  • clinical trial
  • placebo controlled
  • double blind
  • phase ii
  • open label
  • metabolic syndrome
  • glycemic control