Cannabidiol: a Novel Intervention for Cannabis Use Problems?

• ClinicalTrials.gov Identifier: NCT02044809
• Recruitment Status: Completed
• First Posted: January 24, 2014
• Last Update Posted: October 24, 2018
• Sponsor: University College, London
• Information provided by (Responsible Party): University College, London

Tracking Information

• First Submitted Date: January 22, 2014
• First Posted Date: January 24, 2014
• Last Update Posted Date: October 24, 2018
• Study Start Date: March 2014
• Actual Primary Completion Date: February 9, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2014)

• 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.

Original Primary Outcome Measures (submitted: January 22, 2014)

• Urinary 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.
• 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.
• THC-COOH:creatinine below 50ng/ml [ Time Frame: week 4 ]
  This study has two stages. This is the primary endpoint criteria for stage 2.

Current Secondary Outcome Measures (submitted: January 24, 2014)

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.

• Original Secondary Outcome Measures (submitted: January 22, 2014): Psychological Wellbeing, Cognition and Endocannabinoids [ Time Frame: Up to 28 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Cannabis Use Disorder

Intervention

• Drug: Cannabidiol
• Drug: Placebo

Study Arms

• Placebo Comparator: Placebo
  Intervention: Drug: Placebo
• Experimental: Cannabidiol 200mg Oral
  Intervention: Drug: Cannabidiol
• Experimental: Cannabidiol 400mg Oral
  Intervention: Drug: Cannabidiol
• Experimental: Cannabidiol 800mg Oral
  Intervention: Drug: Cannabidiol

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 23, 2018): 82
• Original Estimated Enrollment (submitted: January 22, 2014): 168
• Actual Study Completion Date: June 5, 2017
• Actual Primary Completion Date: February 9, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02044809
• Other Study ID Numbers: 12/0278
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University College, London
• Original Responsible Party: Same as current
• Current Study Sponsor: University College, London
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University College, London
• Verification Date: October 2018