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An Investigation of Mechanisms That Underly Paranoia in Behaviour and Brain That Can Inform Clinical Diagnoses That Include Paranoid Symptoms.
Sponsor: King's College London
Summary
The study team is studying how delta-9-tetrahydrocannabinol (THC) - the component of cannabis that is responsible for "getting people feeling high" - influences how people think about the behaviour of others and a variety of other experiences. The study team is investigating these processes in healthy adults. The study team uses computer-based tasks and questionnaires to understand how people make conclusions about other people's intentions under different circumstances. In this study, the study team uses a placebo-controlled within-participant study design with three different conditions: (i) 1mg/ml THC administration, (ii) 2mg/ml THC administration, and (iii) placebo (Saline) administration, all via an intravenous IV. The study is within-participants, meaning that every participant will experience all three conditions. The study is double blind, meaning that neither the researcher nor the participant will know what condition they will be in on a given study visit. The sequence of conditions is balanced across participants.
Official title: Bridging the Neurocomputational Explanations of Paranoia: From Cognition to Clinic
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-11-01
Completion Date
2028-09-30
Last Updated
2026-10-16
Healthy Volunteers
Yes
Conditions
Interventions
Low-dose THC administration via IV
The study drug for this study is synthetically derived delta-9-tetrahydrocannabinol (THC, International Non-proprietary Name: Dronabinol). THC Active Pharmaceutical Ingredient (API) is provided by Purisys LLC (CDMO), Georgia, USA; and formulated into a solution for intravenous injection by Hybrid Pharma, Florida USA. As detailed in D'Souza et al., 2004, THC is dissolved in 95% ethanol (Agurell et al. 1986) to yield a concentration of 12 mg/ml stock solution which was then passed through a polymer filter, subjected to sterility and pyrogenicity testing, and assayed by gas chromatography mass spectrometry to confirm its concentration and stored at room temperature for future use. Hybrid Pharma will provide 5 ml vials of active drug and matched placebo (ethanol solution without THC). In the high-dose condition, 1mg/ml will be administered over 20min via IV.
High-Dose THC administration via IV
The study drug for this study is synthetically derived delta-9-tetrahydrocannabinol (THC, International Non-proprietary Name: Dronabinol). THC Active Pharmaceutical Ingredient (API) is provided by Purisys LLC (CDMO), Georgia, USA; and formulated into a solution for intravenous injection by Hybrid Pharma, Florida USA. As detailed in D'Souza et al., 2004, THC is dissolved in 95% ethanol (Agurell et al. 1986) to yield a concentration of 12 mg/ml stock solution which was then passed through a polymer filter, subjected to sterility and pyrogenicity testing, and assayed by gas chromatography mass spectrometry to confirm its concentration and stored at room temperature for future use. Hybrid Pharma will provide 5 ml vials of active drug and matched placebo (ethanol solution without THC). In the high-dose condition, 2mg/ml will be administered over 20min via IV.
Saline administration via IV
Saline will be administered intravenously rather than THC
Locations (1)
King's College London
London, United Kingdom