Cannabidiol: a Novel Intervention for Cannabis Use Problems?

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cannabis Use Disorder

Intervention / Treatment
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* Drug: Cannabidiol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: Cannabidiol 200mg Oral<br> | Drug: Cannabidiol<br> <br> |
| Experimental: Cannabidiol 400mg Oral<br> | Drug: Cannabidiol<br> <br> |
| Experimental: Cannabidiol 800mg Oral<br> | Drug: Cannabidiol<br> <br> |

What is the study measuring?
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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 |