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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Intervention: Placebo (Drug)
Cannabidiol 200mg Oral
Intervention: Cannabidiol (Drug)
Cannabidiol 400mg Oral
Intervention: Cannabidiol (Drug)
Cannabidiol 800mg Oral
Intervention: Cannabidiol (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Psychological Wellbeing, Cognition and Endocannabinoids(Up to 28 weeks)