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Cannabidiol: a Novel Intervention for Cannabis Use Problems?

Primary Purpose

Cannabis Use Disorder

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Psychopharmacology Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Cannabidiol 200mg Oral

Cannabidiol 400mg Oral

Cannabidiol 800mg Oral

Arm Description

Outcomes

Primary Outcome Measures

Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine)
This study has two stages. This is the primary endpoint criteria for stage 1.
Number of days abstinent from cannabis
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
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
This study has two stages. This is the primary endpoint criteria for stage 2.

Secondary Outcome Measures

Psychological Wellbeing, Cognition and Endocannabinoids
Psychological Wellbeing, Cognition and Endocannabinoids will be measured by questionnaire methods, neuropsychological testing and biological samples.

Full Information

First Posted
January 22, 2014
Last Updated
October 23, 2018
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02044809
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 9, 2017 (Actual)
Study Completion Date
June 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Cannabidiol 200mg Oral
Arm Type
Experimental
Arm Title
Cannabidiol 400mg Oral
Arm Type
Experimental
Arm Title
Cannabidiol 800mg Oral
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine (THC-COOH:creatinine)
Description
This study has two stages. This is the primary endpoint criteria for stage 1.
Time Frame
up to 4 weeks
Title
Number of days abstinent from cannabis
Description
This study has two stages. This is the primary endpoint criteria for stage 1.
Time Frame
up to 4 weeks
Title
Diagnostic and Statistical Manual- 5 (DSM-5) criteria for moderate cannabis dependence
Description
This study has two stages. This is the primary endpoint criteria for stage 2.
Time Frame
up to 4 weeks
Title
Urinary 11-nor-9-Carboxy-delta-9-tetrahydrocannabinol:creatinine(THC-COOH:creatinine) below 50ng/ml
Description
This study has two stages. This is the primary endpoint criteria for stage 2.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Psychological Wellbeing, Cognition and Endocannabinoids
Description
Psychological Wellbeing, Cognition and Endocannabinoids will be measured by questionnaire methods, neuropsychological testing and biological samples.
Time Frame
Up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Clinical Psychopharmacology Unit
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32735782
Citation
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.
Results Reference
derived

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Cannabidiol: a Novel Intervention for Cannabis Use Problems?

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