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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02044809
Date of registration: 22/01/2014
Prospective Registration: Yes
Primary sponsor: University College, London
Public title: Cannabidiol: a Novel Intervention for Cannabis Use Problems?
Scientific 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.
Date of first enrolment: March 2014
Target sample size: 168
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02044809
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
United Kingdom
Contacts
Key inclusion & exclusion criteria

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.



Age minimum: 16 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Cannabis Use Disorder
Intervention(s)
Drug: Cannabidiol
Drug: Placebo
Primary Outcome(s)
Diagnostic and Statistical Manual- 5 (DSM-5) criteria for moderate cannabis dependence [Time Frame: up to 4 weeks]
Number of days abstinent from cannabis [Time Frame: up to 4 weeks]
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine) [Time Frame: up to 4 weeks]
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml [Time Frame: week 4]
Secondary Outcome(s)
Psychological Wellbeing, Cognition and Endocannabinoids [Time Frame: Up to 28 weeks]
Secondary ID(s)
12/0278
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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