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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
Sponsor:
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE January 24, 2014
Last Update Posted Date October 24, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History Complete list of historical versions of study NCT02044809 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Cannabidiol: a Novel Intervention for Cannabis Use Problems?
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Use Disorder
Intervention  ICMJE
  • Drug: Cannabidiol
  • Drug: Placebo
Study Arms  ICMJE
  • 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 * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2018)
82
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2014)
168
Actual Study Completion Date  ICMJE June 5, 2017
Actual Primary Completion Date February 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02044809
Other Study ID Numbers  ICMJE 12/0278
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University College, London
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP