Cannabidiol: a Novel Intervention for Cannabis Use Problems?
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|ClinicalTrials.gov Identifier: NCT02044809|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2014
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use Disorder||Drug: Cannabidiol Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
|Placebo Comparator: Placebo||Drug: Placebo|
|Experimental: Cannabidiol 200mg Oral||Drug: Cannabidiol|
|Experimental: Cannabidiol 400mg Oral||Drug: Cannabidiol|
|Experimental: Cannabidiol 800mg Oral||Drug: Cannabidiol|
- Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine) [ Time Frame: up to 4 weeks ]This study has two stages. This is the primary endpoint criteria for stage 1.
- Number of days abstinent from cannabis [ Time Frame: 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 [ Time Frame: up to 4 weeks ]This study has two stages. This is the primary endpoint criteria for stage 2.
- Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml [ Time Frame: week 4 ]This study has two stages. This is the primary endpoint criteria for stage 2.
- Psychological Wellbeing, Cognition and Endocannabinoids [ Time Frame: Up to 28 weeks ]Psychological Wellbeing, Cognition and Endocannabinoids will be measured by questionnaire methods, neuropsychological testing and biological samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044809
|Clinical Psychopharmacology Unit|
|London, United Kingdom|