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

Cannabis Use Clinical Trial

— eCBD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170217
• Other study ID #: HR-16/17-4163
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: June 9, 2019

Study information

• Verified date: November 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 9, 2019
• Est. primary completion date: June 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Drug:
• THC
Inhaled cannabis containing 10mg THC
• Cannabidiol
Inhaled cannabis containing 10mg CBD
• Cannabidiol
Inhaled cannabis containing 20mg CBD
• Cannabidiol
Inhaled cannabis containing 30mg CBD

Locations

Country	Name	City	State
United Kingdom	Institute of Psychiatry, Psychology and Neuroscience, King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hopkins Verbal Learning Task	Delayed verbal recall	40-45 minutes post cannabis inhalation
Secondary	Hopkins Verbal Learning Task	Immediate verbal recall	20-40 minutes post cannabis inhalation
Secondary	Forward and Reverse Digit span	Working memory	20-40 minutes post cannabis inhalation
Secondary	Spatial N-back task	Spatial working memory	20-40 minutes post cannabis inhalation
Secondary	Positive and Negative Syndrome Scale	Positive subscale	Baseline; 3-4 hours post cannabis inhalation
Secondary	State Social Paranoia Scale		3-4 hours post cannabis inhalation
Secondary	Community assessment of Psychic Experiences - state		3-4 hours post cannabis inhalation
Secondary	Psychotomimetic states inventory		3-4 hours post cannabis inhalation
Secondary	Visual analogue scales (0 to 100 millimetres)	Feel drug effect; Like drug effect; Want more drug; Mentally impaired; Dry Mouth; Enhanced colour perception; Enhanced sound perception; Want food; Want alcohol; Feel high; Feel anxious; Feel paranoid; Feel tired; Feel calm and relaxed; Feel stoned; The drug effects are pleasurable	Baseline; Pre-cannabis, 10 minutes post-cannabis, 50 minutes post-cannabis, 1 hour 10 minutes post-cannabis, discharge
Secondary	Pleasurable responses - Visual analogue scale (-50 to 50 millimetres)	Increased or decreased pleasure from chocolate and music during intoxication	1 hour post-cannabis
Secondary	Plasma THC concentration		Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis
Secondary	Plasma CBD concentration		Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis
Secondary	Plasma 11-OH-THC concentration		Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis
Secondary	Plasma 11-COOH-THC concentration		Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis
Secondary	Plasma 7-OH-CBD concentration		Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis