CANNABIDIOL (CBD), Pre-Review Report, Agenda Item 5.2

Expert Committee on Drug Dependence

Thirty-ninth Meeting, Geneva, 6-10 November 2017

39th ECDD (2017) Agenda item 5.2 Cannabidiol (CBD)

Contents
Acknowledgements …………………………………………………………………………………………………… 4
Summary ………………………………………………………………………………………………………………….. 5

1. Substance identification ………………………………………………………………………………………….. 6
A. International Nonproprietary Name (INN) ……………………………………………………………….. 6
B. Chemical Abstract Service (CAS) Registry Number …………………………………………………….. 6
C. Other Chemical Names ……………………………………………………………………………………………. 6
D. Trade Names ………………………………………………………………………………………………………….. 6
E. Street Names ………………………………………………………………………………………………………….. 6
F. Physical Appearance ……………………………………………………………………………………………….. 6
G. WHO Review History ………………………………………………………………………………………………. 6

2. Chemistry ………………………………………………………………………………………………………………. 6
A. Chemical Name ………………………………………………………………………………………………………. 6
B. Chemical Structure ………………………………………………………………………………………………….. 7
C. Stereoisomers …………………………………………………………………………………………………………. 7
D. Methods and Ease of Illicit Manufacturing …………………………………………………………………. 7
E. Chemical Properties ………………………………………………………………………………………………… 9
F. Identification and Analysis ……………………………………………………………………………………….. 9

3. Ease of Convertibility Into Controlled Substances …………………………………………………… 10

4. General Pharmacology ………………………………………………………………………………………….. 11
A. Routes of administration and dosage ……………………………………………………………………….. 11
B. Pharmacokinetics ………………………………………………………………………………………………….. 11
C. Pharmacodynamics ……………………………………………………………………………………………….. 12

5. Toxicology ……………………………………………………………………………………………………………. 13

6. Adverse Reactions in Humans ……………………………………………………………………………….. 13

7. Dependence Potential ……………………………………………………………………………………………. 14
A. Animal Studies ………………………………………………………………………………………………………. 14
B. Human Studies ………………………………………………………………………………………………………. 14

8. Abuse Potential …………………………………………………………………………………………………….. 14
A. Animal Studies ………………………………………………………………………………………………………. 14
B. Human Studies ………………………………………………………………………………………………………. 14

9. Therapeutic Applications and Extent of Therapeutic Use and Epidemiology of Medical Use………………………………………………………………………………………………………………………. 15

10. Listing on the WHO Model List of Essential Medicines ……………………………………………. 19

11. Marketing Authorizations (as a Medicinal Product) ………………………………………………… 19

12. Industrial Use ………………………………………………………………………………………………………. 19

13. Non-Medical Use, Abuse and Dependence ……………………………………………………………… 19

14. Nature and Magnitude of Public Health Problems Related to Misuse, Abuse and Dependence ………………………………………………………………………………………………………….. 20

15. Licit Production, Consumption and International Trade ………………………………………….. 20

16. Illicit Manufacture and Traffic and Related Information …………………………………………. 20

17. Current International Controls and Their Impact ……………………………………………………. 20

18. Current and Past National Controls ……………………………………………………………………….. 20

19. Other Medical and Scientific Matters Relevant for a Recommendation on the Scheduling of the Substance……………………………………………………………………………………………………. 21

References ………………………………………………………………………………………………………………. 22
Annex 1: Report on WHO Questionnaire for Review of Psychoactive Substances for the 39th ECDD: Evaluation of Cannabidiol …………………………………………………………………… 27

 

Cannabidiol (CBD) is one of the naturally occurring cannabinoids found in cannabis plants. It is a 21 carbon terpenophenolic compound which is formed following decarboxylation from a cannabidiolic acid precursor, although it can also be produced synthetically.

CBD can be converted to tetrahydrocannabinol (THC) under experimental conditions; however, this does not appear to occur to any significant effect in patients undergoing CBD treatment.

In experimental models of abuse liability, CBD appears to have little effect on conditioned place preference or intracranial self-stimulation. In an animal drug discrimination model CBD failed to substitute for THC. In humans, CBD exhibits no effects indicative of any abuse or dependence potential. CBD has been demonstrated as an effective treatment of epilepsy in several clinical trials, with one pure CBD product (Epidiolex®) currently in Phase III trials. There is also preliminary evidence that CBD may be a useful treatment for a number of other medical conditions.

There is unsanctioned medical use of CBD based products with oils, supplements, gums, and high concentration extracts available online for the treatment of many ailments.

CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications.

Several countries have modified their national controls to accommodate CBD as a medicinal product. To date, there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD.

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