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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Cannabidiol 200mg Oral | Experimental |
| |
| Cannabidiol 400mg Oral | Experimental |
| |
| Cannabidiol 800mg Oral | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug |
| ||
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Psychopharmacology Unit | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36598543 | Derived | Lees R, Hines LA, Hindocha C, Baio G, Shaban NDC, Stothart G, Mofeez A, Morgan CJA, Curran HV, Freeman TP. Effect of four-week cannabidiol treatment on cognitive function: secondary outcomes from a randomised clinical trial for the treatment of cannabis use disorder. Psychopharmacology (Berl). 2023 Feb;240(2):337-346. doi: 10.1007/s00213-022-06303-5. Epub 2023 Jan 4. | |
| 32735782 |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Drug |
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| 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. |