Cannabidiol: a novel intervention for cannabis use problems?

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 in a young cannabis dependent population. - Cannabidiol: a novel intervention for cannabis use problems?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000361-36-GB

Enrollment

168

Registered

2013-08-19

Start date

2013-11-12

Completion date

Unknown

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'Moderate cannabis use disorder' as defined by the diagnostic criteria in DSM-5 (published in May 2013), similar to the previous term 'cannabis dependence' (DSM-4). MedDRA version: 16.0 Level: LLT Classification code 10007177 Term: Cannabis dependence System Organ Class: 100000004873

Interventions

Product Name: Synthetic Cannabidiol 50mg Product Code: CBD50 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Synthetic Cannabidiol CAS Number: 13956-29-1 Current Sponsor code: 12/0278 Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age: between 16 and 26 years old 2.Gender: all 3.All will meet DSM-5 criteria for moderate cannabis use disorder (=4 DSM-5 criteria). DSM refers to the Diagnostic and Statistical Manual for Mental Disorders, widely used to diagnose mental illness in psychiatry. Please note that the diagnostic criteria of 'cannabis dependence' in the previous edition (DSM-4) was replaced with 'cannabis use disorder' (DSM-5) in May 2013. 4.Express a desire to quit using cannabis within the next four weeks and report =1 previous failed quit attempt 5.Smoke tobacco with cannabis 6.Provide a urine sample positive for cannabis (qualitative urine screen) 7.Vital signs within healthy limits (blood pressure, heart rate, respiratory peak flow) 8.Capacity to give informed consent as defined by GCP guidelines 9.Females of childbearing potential and males must be willing to use an effective method of contraception including oral, injected or implanted hormonal methods of contraception; placement of an IUS (intrauterine system) or IUD (intrauterine device); barrier method of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository; male sterilization); true abstinence of birth control; abstinence from the time consent is signed until 6 weeks after treatment discontinuation 10.Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 138 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1.Females who are pregnant or breastfeeding 2.Allergies to IMP or placebo and its excipients 3.>twice/month use of other illicit drugs 4.Current prescribed psychotropic use 5.Outside normal Body Mass Index (30) 6.Any physical health problem as deemed clinically significant by the investigator team 7.Non English speakers (because of verbal test assessments)

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the most effective dose of cannabidiol for reducing cannabis use, and is this dose effective as a treatment for cannabis dependence?;Secondary Objective: Does cannabidiol improve cognitive function (e.g. memory), psychological wellbeing, and quality of life in depedendent cannabis users? Are these effects maintained up to 12 weeks after treatment ends and are they associated with biological changes that have been linked to heavy cannabis use?;Primary end point(s): For stage 1: Levels of cannabis use, as indexed by self report (number of days abstinent according to Time Line Follow Back interview) and objective assessment of cannabis use in urine (THC-COOH, corrected for creatinine) For state 2: Cannabis dependence as indexed by diagnosis using a DSM-5 questionnaire (less then 4 DSM-5 cannabis use disorder) criteria and cessation of cannabis use as evidenced by urinary THCCOOH (corrected for creatinine) below 50ng/ml.;Timepoint(s) of evaluation of this end point: Timepoints of evaluation will be made at week 4 (end of treatment)and at week 12.	—

Measure

Time frame

Main Objective: What is the most effective dose of cannabidiol for reducing cannabis use, and is this dose effective as a treatment for cannabis dependence?;Secondary Objective: Does cannabidiol improve cognitive function (e.g. memory), psychological wellbeing, and quality of life in depedendent cannabis users? Are these effects maintained up to 12 weeks after treatment ends and are they associated with biological changes that have been linked to heavy cannabis use?;Primary end point(s): For stage 1: Levels of cannabis use, as indexed by self report (number of days abstinent according to Time Line Follow Back interview) and objective assessment of cannabis use in urine (THC-COOH, corrected for creatinine) For state 2: Cannabis dependence as indexed by diagnosis using a DSM-5 questionnaire (less then 4 DSM-5 cannabis use disorder) criteria and cessation of cannabis use as evidenced by urinary THCCOOH (corrected for creatinine) below 50ng/ml.;Timepoint(s) of evaluation of this end point: Timepoints of evaluation will be made at week 4 (end of treatment)and at week 12.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are to determine whether MEDmg cannabidiol can significantly (a) reduce the number of participants meeting a cut-off of less than 4 days/week cannabis use (e.g. weekend only use); (b) alleviate withdrawal symptoms on the Cannabis Withdrawal Scale (total score) to baseline levels of withdrawal at study entry; (c) reduce adverse effects of cannabis use including cognition, psychological well-being, quality of life and nicotine dependence. Furthermore, we aim to investigate whether the efficacy of cannabidiol is maintained up to 12 weeks after treatment, and whether it is associated with changes in the endocannabinoid system (anandamide and 2-AG in plasma).;Timepoint(s) of evaluation of this end point: Timepoints of evaluation will be made at week 4 (end of treatment)and at all follow up weeks (6,8,12,16,20 & 24)	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are to determine whether MEDmg cannabidiol can significantly (a) reduce the number of participants meeting a cut-off of less than 4 days/week cannabis use (e.g. weekend only use); (b) alleviate withdrawal symptoms on the Cannabis Withdrawal Scale (total score) to baseline levels of withdrawal at study entry; (c) reduce adverse effects of cannabis use including cognition, psychological well-being, quality of life and nicotine dependence. Furthermore, we aim to investigate whether the efficacy of cannabidiol is maintained up to 12 weeks after treatment, and whether it is associated with changes in the endocannabinoid system (anandamide and 2-AG in plasma).;Timepoint(s) of evaluation of this end point: Timepoints of evaluation will be made at week 4 (end of treatment)and at all follow up weeks (6,8,12,16,20 & 24)

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Countries

United Kingdom

Contacts

Public ContactAlison Evans

Joint Research Office, UCL

a.j.evans@ucl.ac.uk02076796802

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026