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OpenTrials
Completed

NCT Number: NCT02044809

Cannabidiol: a Novel Intervention for Cannabis Use Problems?

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.

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Key information

Conditions

Cannabis Use Disorder

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Psychopharmacology Unit

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2014
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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