drugset / Trial / NCT04605393

Does Cannabidiol Attenuate the Acute Effects of ∆9-tetrahydrocannabinol Intoxication in Individuals Diagnosed With Schizophrenia? A Double-blind, Randomised, Placebo-controlled Experimental Study

NCT04605393 ↗

Completed 36 enrolled King's College London
RandomizedCrossoverQuadruple-blindBasic science

Summary

This study will recruit schizophrenia patients who use cannabis recreationally. Each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study and two days of testing. Participants will be administered, in a randomized order, a pre-treatment with either CBD (1000mg) orally or a matching placebo. On both experiments, participants will then inhale cannabis containing THC. The THC administration will follow a standardised inhalation procedure using a medical-grade vaporizer device. Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences. The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.

Timeline

Start
2021-01-01
Primary completion
2023-07-07
Completion
2023-07-07

Outcome

Missed primary endpoint

paper Delayed verbal recall after cannabis administration was 3.5 words (95% confidence interval [CI]: 2.5-4.5) following pre-treatment with CBD, compared to 4.8 words PMID 40702165 ↗

paper mean difference [MD] = -1.3 [95% CI: -2.0 to -0.6]; p = 0.001 PMID 40702165 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 1000 mg Oral
Subject Dronabinol Other / unclassified 20 mg Inhaled
Subject Dronabinol Other / unclassified 60 mg Inhaled