Cannabidiol: a Novel Intervention for Cannabis Use Problems?
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|ClinicalTrials.gov Identifier: NCT02044809|
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : October 24, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use Disorder||Drug: Cannabidiol Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 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|
|Actual Primary Completion Date :||February 9, 2017|
|Actual Study Completion Date :||June 5, 2017|
|Placebo Comparator: Placebo||
|Experimental: Cannabidiol 200mg Oral||
|Experimental: Cannabidiol 400mg Oral||
|Experimental: Cannabidiol 800mg Oral||
- 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.
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|Ages Eligible for Study:||16 Years to 60 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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|
|Responsible Party:||University College, London|
|Other Study ID Numbers:||
|First Posted:||January 24, 2014 Key Record Dates|
|Last Update Posted:||October 24, 2018|
|Last Verified:||October 2018|