Cannabidiol: a Novel Intervention for Cannabis Use Problems?

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02044809
• Date of registration: 22/01/2014
• Prospective Registration: Yes
• Primary sponsor: University College, London
• Public title: Cannabidiol: a Novel Intervention for Cannabis Use Problems?
• Scientific title: A Phase IIa/b, Randomised, Double-blind, Placebo-controlled, Single-site, Parallel Group Clinical Trial to Examine Cannabidiol (CBD) as a Pharmacological Treatment for Cannabis Dependence.
• Date of first enrolment: March 2014
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02044809
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged between 16 and 60 years old.

- Meet DSM-5 criteria for moderate cannabis use disorder (=4 DSM-5 criteria)

- Express desire to quit using cannabis within the next four weeks,

- Have =1 previous failed quit attempt.

- Smoke tobacco with cannabis,

- Test positive for recent cannabis use according to urine analysis,

- Vital signs within healthy limits and have capacity to give consent

Exclusion Criteria:

- Not willing to use effective contraception from when consent is taken to 6 weeks after
treatment has stopped

- Positive pregnancy test or breastfeeding

- Allergies to the Investigational Medicinal Product (IMP) or placebo and its excipients

- >twice/month use of other illicit drugs

- Outside normal Body Mass Index (BMI)

- A physical health problem deemed clinically significant

- The use of current prescribed psychotropic drugs

- Current or prior self-reported diagnosis of a psychotic disorder

- Non-English speakers due to verbal assessments.



Age minimum: 16 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cannabis Use Disorder

Intervention(s)

Drug: Placebo

Drug: Cannabidiol

Primary Outcome(s)

Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml [Time Frame: week 4]

Number of days abstinent from cannabis [Time Frame: up to 4 weeks]

Diagnostic and Statistical Manual- 5 (DSM-5) criteria for moderate cannabis dependence [Time Frame: up to 4 weeks]

Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine) [Time Frame: up to 4 weeks]

Secondary Outcome(s)

Psychological Wellbeing, Cognition and Endocannabinoids [Time Frame: Up to 28 weeks]

Secondary ID(s)

12/0278

Source(s) of Monetary Support

Please refer to primary and secondary sponsors