NCT02044809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2017

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

January 22, 2014

Last Update Submit

October 23, 2018

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (4)

  • 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.

    up to 4 weeks

  • Number of days abstinent from cannabis

    This study has two stages. This is the primary endpoint criteria for stage 1.

    up to 4 weeks

  • 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.

    up to 4 weeks

  • 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.

    week 4

Secondary Outcomes (1)

  • Psychological Wellbeing, Cognition and Endocannabinoids

    Up to 28 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Cannabidiol 200mg Oral

EXPERIMENTAL
Drug: Cannabidiol

Cannabidiol 400mg Oral

EXPERIMENTAL
Drug: Cannabidiol

Cannabidiol 800mg Oral

EXPERIMENTAL
Drug: Cannabidiol

Interventions

CannabidiolDRUG
Cannabidiol 200mg OralCannabidiol 400mg OralCannabidiol 800mg Oral
PlaceboDRUG
Placebo

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Psychopharmacology Unit

London, United Kingdom

Location

Related Publications (2)

  • Lees R, Hines LA, Hindocha C, Baio G, Shaban NDC, Stothart G, Mofeez A, Morgan CJA, Curran HV, Freeman TP. Effect of four-week cannabidiol treatment on cognitive function: secondary outcomes from a randomised clinical trial for the treatment of cannabis use disorder. Psychopharmacology (Berl). 2023 Feb;240(2):337-346. doi: 10.1007/s00213-022-06303-5. Epub 2023 Jan 4.

    PMID: 36598543DERIVED

  • 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.

    PMID: 32735782DERIVED

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

March 1, 2014

Primary Completion

February 9, 2017

Study Completion

June 5, 2017

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations

GB(1)