Cannabis Use
Conditions
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.
Interventions
DRUGTHC
Inhaled cannabis containing 10mg THC
DRUGCannabidiol
Inhaled cannabis containing 10mg CBD
Sponsors
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hopkins Verbal Learning Task | 40-45 minutes post cannabis inhalation | Delayed verbal recall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma CBD concentration | Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis | — |
| Plasma 11-OH-THC concentration | Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis | — |
| Hopkins Verbal Learning Task | 20-40 minutes post cannabis inhalation | Immediate verbal recall |
| Forward and Reverse Digit span | 20-40 minutes post cannabis inhalation | Working memory |
| Spatial N-back task | 20-40 minutes post cannabis inhalation | Spatial working memory |
| Positive and Negative Syndrome Scale | Baseline; 3-4 hours post cannabis inhalation | Positive subscale |
| Plasma THC concentration | Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis | — |
| Community assessment of Psychic Experiences - state | 3-4 hours post cannabis inhalation | — |
| Psychotomimetic states inventory | 3-4 hours post cannabis inhalation | — |
| Visual analogue scales (0 to 100 millimetres) | Baseline; Pre-cannabis, 10 minutes post-cannabis, 50 minutes post-cannabis, 1 hour 10 minutes post-cannabis, discharge | * 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) | 1 hour post-cannabis | Increased or decreased pleasure from chocolate and music during intoxication |
| Plasma 11-COOH-THC concentration | Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis | — |
| Plasma 7-OH-CBD concentration | Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis | — |
| State Social Paranoia Scale | 3-4 hours post cannabis inhalation | — |
Countries
United Kingdom
Outcome results
None listed