Clinical trial NCT02044809: Cannabidiol: a Novel Intervention for Cannabis Use Problems?
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Use Disorder
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 82
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine)
timeFrame: up to 4 weeks
measure: Number of days abstinent from cannabis
timeFrame: up to 4 weeks
measure: Diagnostic and Statistical Manual- 5 (DSM-5) criteria for moderate cannabis dependence
timeFrame: up to 4 weeks
measure: Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml
timeFrame: week 4
Secondary outcomes:
measure: Psychological Wellbeing, Cognition and Endocannabinoids
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Clinical Psychopharmacology Unit
Study officials:
References:
citation: 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.