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

Primary Purpose

Cannabis Use

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

THC

Cannabidiol

About this trial

This is an interventional basic science trial for Cannabis Use

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

CBD:THC 0:1

CBD:THC 1:1

CBD:THC 2:1

CBD:THC 3:1

Arm Description

Inhalation of cannabis containing only THC

Inhalation of cannabis containing THC and CBD

Outcomes

Primary Outcome Measures

Hopkins Verbal Learning Task

Delayed verbal recall

Secondary Outcome Measures

Hopkins Verbal Learning Task

Immediate verbal recall

Forward and Reverse Digit span

Working memory

Spatial N-back task

Spatial working memory

Positive and Negative Syndrome Scale

Positive subscale

State Social Paranoia Scale

Community assessment of Psychic Experiences - state

Psychotomimetic states inventory

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

Pleasurable responses - Visual analogue scale (-50 to 50 millimetres)

Increased or decreased pleasure from chocolate and music during intoxication

Plasma THC concentration

Plasma CBD concentration

Plasma 11-OH-THC concentration

Plasma 11-COOH-THC concentration

Plasma 7-OH-CBD concentration

Full Information

NCT ID

NCT05170217

First Posted

November 17, 2021

Last Updated

December 9, 2021

Sponsor

King's College London

1. Study Identification

Unique Protocol Identification Number

NCT05170217

Brief Title

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

Acronym

eCBD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

June 9, 2019 (Actual)

Study Completion Date

June 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis Use

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBD:THC 0:1

Arm Type

Experimental

Arm Description

Inhalation of cannabis containing only THC

Arm Title

CBD:THC 1:1

Arm Type

Experimental

Arm Description

Inhalation of cannabis containing THC and CBD

Arm Title

CBD:THC 2:1

Arm Type

Experimental

Arm Description

Inhalation of cannabis containing THC and CBD

Arm Title

CBD:THC 3:1

Arm Type

Experimental

Arm Description

Inhalation of cannabis containing THC and CBD

Intervention Type

Drug

Intervention Name(s)

THC

Intervention Description

Inhaled cannabis containing 10mg THC

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Intervention Description

Inhaled cannabis containing 10mg CBD

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Intervention Description

Inhaled cannabis containing 20mg CBD

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Intervention Description

Inhaled cannabis containing 30mg CBD

Primary Outcome Measure Information:

Title

Hopkins Verbal Learning Task

Description

Delayed verbal recall

Time Frame

40-45 minutes post cannabis inhalation

Secondary Outcome Measure Information:

Title

Hopkins Verbal Learning Task

Description

Immediate verbal recall

Time Frame

20-40 minutes post cannabis inhalation

Title

Forward and Reverse Digit span

Description

Working memory

Time Frame

20-40 minutes post cannabis inhalation

Title

Spatial N-back task

Description

Spatial working memory

Time Frame

20-40 minutes post cannabis inhalation

Title

Positive and Negative Syndrome Scale

Description

Positive subscale

Time Frame

Baseline; 3-4 hours post cannabis inhalation

Title

State Social Paranoia Scale

Time Frame

3-4 hours post cannabis inhalation

Title

Community assessment of Psychic Experiences - state

Time Frame

3-4 hours post cannabis inhalation

Title

Psychotomimetic states inventory

Time Frame

3-4 hours post cannabis inhalation

Title

Visual analogue scales (0 to 100 millimetres)

Description

Time Frame

Baseline; Pre-cannabis, 10 minutes post-cannabis, 50 minutes post-cannabis, 1 hour 10 minutes post-cannabis, discharge

Title

Pleasurable responses - Visual analogue scale (-50 to 50 millimetres)

Description

Increased or decreased pleasure from chocolate and music during intoxication

Time Frame

1 hour post-cannabis

Title

Plasma THC concentration

Time Frame