Cannabidiol: a Novel Intervention for Cannabis Use Problems?

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.

The purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can offer an effective treatment for cannabis dependence.

Study Overview

• Status: Completed
• Conditions: Cannabis Use Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Cannabidiol

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Clinical Psychopharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Cannabidiol 200mg Oral	Drug: Cannabidiol
Experimental: Cannabidiol 400mg Oral	Drug: Cannabidiol
Experimental: Cannabidiol 800mg Oral	Drug: Cannabidiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine)	This study has two stages. This is the primary endpoint criteria for stage 1.	up to 4 weeks
Number of days abstinent from cannabis	This study has two stages. This is the primary endpoint criteria for stage 1.	up to 4 weeks
Diagnostic and Statistical Manual- 5 (DSM-5) criteria for moderate cannabis dependence	This study has two stages. This is the primary endpoint criteria for stage 2.	up to 4 weeks
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml	This study has two stages. This is the primary endpoint criteria for stage 2.	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Wellbeing, Cognition and Endocannabinoids	Psychological Wellbeing, Cognition and Endocannabinoids will be measured by questionnaire methods, neuropsychological testing and biological samples.	Up to 28 weeks

Collaborators and Investigators

• Sponsor: University College, London

Publications and helpful links

General Publications

• Freeman TP, Hindocha C, Baio G, Shaban NDC, Thomas EM, Astbury D, Freeman AM, Lees R, Craft S, Morrison PD, Bloomfield MAP, O'Ryan D, Kinghorn J, Morgan CJA, Mofeez A, Curran HV. Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial. Lancet Psychiatry. 2020 Oct;7(10):865-874. doi: 10.1016/S2215-0366(20)30290-X. Epub 2020 Jul 28.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 9, 2017
• Study Completion (Actual): June 5, 2017

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 24, 2014

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 12/0278