Cannabidiol: a Novel Intervention for Cannabis Use Problems?

Phase 2

Completed

• Conditions: Cannabis Use Disorder
• Interventions: Drug: Placebo; Drug: Cannabidiol

• Registration Number: NCT02044809
• Lead Sponsor: University College, London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-03
• Primary Completion: 2017-02-09
• Study Completion: 2017-06-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cannabidiol 200mg Oral	Cannabidiol	-
Cannabidiol 400mg Oral	Cannabidiol	-
Cannabidiol 800mg Oral	Cannabidiol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Psychological Wellbeing, Cognition and Endocannabinoids	Up to 28 weeks	Psychological Wellbeing, Cognition and Endocannabinoids will be measured by questionnaire methods, neuropsychological testing and biological samples.

Trial Locations

Locations (1)

Clinical Psychopharmacology Unit; 🇬🇧 London, United Kingdom