Cannabidiol: a Novel Intervention for Cannabis Use Problems?

Cannabis Use Disorder Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044809
• Other study ID #: 12/0278
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: June 5, 2017

Study information

• Verified date: October 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 5, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse

Intervention

Drug:
• Cannabidiol

• Placebo

Locations

Country	Name	City	State
United Kingdom	Clinical Psychopharmacology Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of days abstinent from cannabis	This study has two stages. This is the primary endpoint criteria for stage 1.	up to 4 weeks
Primary	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
Primary	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	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