Self-Titration Produced Different Capsule Counts in Active and Placebo Chemotherapy Arms
The chemotherapy study permitted capsule adjustment according to nausea and side effects. Active and placebo participants consequently did not take the same median number of capsules per dose.
Capsule content and regimen were specified
Each active capsule contained 2.5 milligrams of THC and 2.5 milligrams of CBD. Treatment was scheduled three times daily around chemotherapy, with protocol-limited self-titration. Median use per dose was two active capsules versus three placebo capsules.
Actual use followed the assigned treatment strategy
The active median corresponded to five milligrams of each cannabinoid per administration. It was not the dose received by every participant at every administration. Because symptom experience influenced titration, observed capsule count was partly an outcome of tolerability and perceived need.
The study was not a randomized comparison of achieved doses
Randomization compared active treatment strategy with placebo strategy. It did not separately randomize participants to every final capsule count. An association between a larger count and an outcome could therefore reflect why participants adjusted treatment. Nor does a placebo capsule supply a cannabinoid dose for a mass-matched exposure comparison. The findings concern a particular supervised, adjustable regimen added to standard antiemetics, rather than proof that its median dose is optimal or appropriate for an individual outside the trial.
Related analysis: the trial’s main results and limitations.
