Implications for blinding in clinical trials with THC-containing cannabinoids based on the CANNA-TICS trial

ABSTRACT: Randomized double-blind placebo-controlled trials (RCTs) are regarded as the gold standard for clinical trials. While there are established standards to avoid unblinding, in RCTs using tetrahydrocannabinol (THC) containing cannabinoids, however, accidental unblinding and intentional self-unbinding must be considered as a particular issue, since THC tests are widely available. To investigate unblinding rates in an RCT using a THC-containing cannabinoid, we re-contacted 54 out of 97 participants of the CANNA-TICS trial who had participated in our study center in Hannover. Of the 54 participants, 53 could be reached. Of these, one participant (2%) stated that she had unblinded herself intentionally during the treatment phase, and another three patients (6%) reported intentional unblinding aft

SUBMITTER: Muller-Vahl K 

PROVIDER: S-EPMC9533554 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature