Reducing the Harmful Effects of Cannabis Use: Finding the Optimal CBD:THC Ratio

NCT ID: NCT05170217

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2019-06-09

Brief Summary

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This study will recruit healthy volunteers who use cannabis infrequently. Each participant will attend the laboratory on five occasions: an initial visit to check that they are safe to join the study and four days of testing.

Participants will be administered, in a randomized order, vaporized cannabis containing one of four different ratios of CBD:THC (0:1, 1:1, 2:1, 3:1). The cannabis 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.

Detailed Description

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Conditions

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Cannabis Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CBD:THC 0:1

Inhalation of cannabis containing only THC

Group Type EXPERIMENTAL

THC

Intervention Type DRUG

Inhaled cannabis containing 10mg THC

CBD:THC 1:1

Inhalation of cannabis containing THC and CBD

Group Type EXPERIMENTAL

THC

Intervention Type DRUG

Inhaled cannabis containing 10mg THC

Cannabidiol

Intervention Type DRUG

Inhaled cannabis containing 10mg CBD

CBD:THC 2:1

Inhalation of cannabis containing THC and CBD

Group Type EXPERIMENTAL

THC

Intervention Type DRUG

Inhaled cannabis containing 10mg THC

Cannabidiol

Intervention Type DRUG

Inhaled cannabis containing 20mg CBD

CBD:THC 3:1

Inhalation of cannabis containing THC and CBD

Group Type EXPERIMENTAL

THC

Intervention Type DRUG

Inhaled cannabis containing 10mg THC

Cannabidiol

Intervention Type DRUG

Inhaled cannabis containing 30mg CBD

Interventions

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THC

Inhaled cannabis containing 10mg THC

Intervention Type DRUG

Cannabidiol

Inhaled cannabis containing 10mg CBD

Intervention Type DRUG

Cannabidiol

Inhaled cannabis containing 20mg CBD

Intervention Type DRUG

Cannabidiol

Inhaled cannabis containing 30mg CBD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female and male volunteers aged 21-50
* Have used cannabis at least once
* Willing to provide written informed consent
* Willing to provide blood samples
* Fluent English speaker

Exclusion Criteria

* Past or present major mental illness
* Past or present major physical illness
* Past or present substance use disorder
* Past or present use of anti-psychotic or anti-depressant medications
* First degree relative with psychotic disorder
* Currently taking psychotropic medication
* Positive urine drug screen at screening or experimental visits
* Use of alcohol 24h prior to experimental visit or tobacco on the day of experiment
* Pregnancy (current or planned) or lactation in women
* Significant abnormality detected during physical examination at screening visit
* Cannabis use (defined as days in which cannabis is used recreationally) more than once per week on average over the last 12 months
* Any past use of synthetic cannabinoids
* Score of 5 and above on the Fagerstrom Nicotine dependence questionnaire
* BMI classified as obese or underweight
* Taken part in any drug study within the last 30 days or taking part in another study over the course of the trial
* Known drug sensitivity/allergy towards cannabis or Lorazepam
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Psychiatry, Psychology and Neuroscience, King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Oliver D, Englund A, Chesney E, Chester L, Wilson J, Sovi S, Wigroth S, Hodsoll J, Strang J, Murray RM, Freeman TP, Fusar-Poli P, McGuire P. Cannabidiol does not attenuate acute delta-9-tetrahydrocannabinol-induced attentional bias in healthy volunteers: A randomised, double-blind, cross-over study. Addiction. 2024 Feb;119(2):322-333. doi: 10.1111/add.16353. Epub 2023 Oct 11.

Reference Type DERIVED
PMID: 37821096 (View on PubMed)

Chester LA, Englund A, Chesney E, Oliver D, Wilson J, Sovi S, Dickens AM, Oresic M, Linderman T, Hodsoll J, Minichino A, Strang J, Murray RM, Freeman TP, McGuire P. Effects of Cannabidiol and Delta-9-Tetrahydrocannabinol on Plasma Endocannabinoid Levels in Healthy Volunteers: A Randomized Double-Blind Four-Arm Crossover Study. Cannabis Cannabinoid Res. 2024 Feb;9(1):188-198. doi: 10.1089/can.2022.0174. Epub 2022 Dec 9.

Reference Type DERIVED
PMID: 36493386 (View on PubMed)

Other Identifiers

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HR-16/17-4163

Identifier Type: -

Identifier Source: org_study_id