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

King's College London

Status: Completed

Conditions: Cannabis Use

Treatments: Drug: Cannabidiol; Drug: THC

Study type: Interventional

Funder types: Other

Identifiers

NCT05170217

HR-16/17-4163

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

46 participants in 4 patient groups

CBD:THC 0:1

Experimental group

Description:

Inhalation of cannabis containing only THC

Treatment:

Drug: THC

CBD:THC 1:1

Experimental group

Description:

Inhalation of cannabis containing THC and CBD

Treatment:

Drug: Cannabidiol

Drug: THC

Drug: Cannabidiol

Drug: Cannabidiol

CBD:THC 2:1

Experimental group

Description:

Inhalation of cannabis containing THC and CBD

Treatment:

Drug: Cannabidiol

Drug: THC

Drug: Cannabidiol

Drug: Cannabidiol

CBD:THC 3:1

Experimental group

Description:

Inhalation of cannabis containing THC and CBD

Treatment:

Drug: Cannabidiol

Drug: THC

Drug: Cannabidiol

Drug: Cannabidiol