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Cannabidiol: a Novel Intervention for Cannabis Use Problems?

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT02044809
First received: January 22, 2014
Last updated: May 2, 2017
Last verified: October 2016
  Purpose
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 Intervention Phase
Cannabis Use Disorder Drug: Cannabidiol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 168
Study Start Date: March 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Cannabidiol 200mg Oral Drug: Cannabidiol
Experimental: Cannabidiol 400mg Oral Drug: Cannabidiol
Experimental: Cannabidiol 800mg Oral Drug: Cannabidiol

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044809

Locations
United Kingdom
Clinical Psychopharmacology Unit
London, United Kingdom
Sponsors and Collaborators
University College, London
  More Information

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02044809     History of Changes
Other Study ID Numbers: 12/0278
Study First Received: January 22, 2014
Last Updated: May 2, 2017

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017