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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05170217
Recruitment Status : Completed
First Posted : December 27, 2021
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
King's College London

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.


Condition or disease Intervention/treatment Phase
Cannabis Use Drug: THC Drug: Cannabidiol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Reducing the Harmful Effects of Cannabis Use: Finding the Optimal CBD:THC Ratio
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : June 9, 2019
Actual Study Completion Date : June 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: CBD:THC 0:1
Inhalation of cannabis containing only THC
Drug: THC
Inhaled cannabis containing 10mg THC

Experimental: CBD:THC 1:1
Inhalation of cannabis containing THC and CBD
Drug: THC
Inhaled cannabis containing 10mg THC

Drug: Cannabidiol
Inhaled cannabis containing 10mg CBD

Experimental: CBD:THC 2:1
Inhalation of cannabis containing THC and CBD
Drug: THC
Inhaled cannabis containing 10mg THC

Drug: Cannabidiol
Inhaled cannabis containing 20mg CBD

Experimental: CBD:THC 3:1
Inhalation of cannabis containing THC and CBD
Drug: THC
Inhaled cannabis containing 10mg THC

Drug: Cannabidiol
Inhaled cannabis containing 30mg CBD




Primary Outcome Measures :
  1. Hopkins Verbal Learning Task [ Time Frame: 40-45 minutes post cannabis inhalation ]
    Delayed verbal recall


Secondary Outcome Measures :
  1. Hopkins Verbal Learning Task [ Time Frame: 20-40 minutes post cannabis inhalation ]
    Immediate verbal recall

  2. Forward and Reverse Digit span [ Time Frame: 20-40 minutes post cannabis inhalation ]
    Working memory

  3. Spatial N-back task [ Time Frame: 20-40 minutes post cannabis inhalation ]
    Spatial working memory

  4. Positive and Negative Syndrome Scale [ Time Frame: Baseline; 3-4 hours post cannabis inhalation ]
    Positive subscale

  5. State Social Paranoia Scale [ Time Frame: 3-4 hours post cannabis inhalation ]
  6. Community assessment of Psychic Experiences - state [ Time Frame: 3-4 hours post cannabis inhalation ]
  7. Psychotomimetic states inventory [ Time Frame: 3-4 hours post cannabis inhalation ]
  8. Visual analogue scales (0 to 100 millimetres) [ Time Frame: 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

  9. Pleasurable responses - Visual analogue scale (-50 to 50 millimetres) [ Time Frame: 1 hour post-cannabis ]
    Increased or decreased pleasure from chocolate and music during intoxication

  10. Plasma THC concentration [ Time Frame: Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis ]
  11. Plasma CBD concentration [ Time Frame: Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis ]
  12. Plasma 11-OH-THC concentration [ Time Frame: Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis ]
  13. Plasma 11-COOH-THC concentration [ Time Frame: Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis ]
  14. Plasma 7-OH-CBD concentration [ Time Frame: Pre-cannabis, 0 minutes post-cannabis, 5 minutes post-cannabis, 15 minutes post-cannabis, 90 minutes post-cannabis ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05170217


Locations
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United Kingdom
Institute of Psychiatry, Psychology and Neuroscience, King's College London
London, United Kingdom, SE5 8AF
Sponsors and Collaborators
King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT05170217    
Other Study ID Numbers: HR-16/17-4163
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cannabidiol
Anticonvulsants