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Cannabidiol: a Novel Intervention for Cannabis Use Problems?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: Cannabidiol Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: Cannabidiol 200mg Oral Drug: Cannabidiol
Experimental: Cannabidiol 400mg Oral Drug: Cannabidiol
Experimental: Cannabidiol 800mg Oral Drug: Cannabidiol


Outcome Measures
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Primary Outcome Measures :
  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.

  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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044809


Locations
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United Kingdom
Clinical Psychopharmacology Unit
London, United Kingdom
Sponsors and Collaborators
University College, London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02044809    
Other Study ID Numbers: 12/0278
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Cannabidiol
Anticonvulsants