Cannabidiol: a novel intervention for cannabis use problems?

Phase 1

• 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: 16.0Level: LLTClassification code 10007177Term: Cannabis dependenceSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-000361-36-GB
• Lead Sponsor: Joint Research Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-19
• Study Completion: 2017-06-05
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 82

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

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 (<16 or >30) 6.Any physical health problem as deemed clinically significant by the investigator team 7.Non English speakers (because of verbal test assessments)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified