drugset / Trial / NCT02044809

Cannabidiol: a Novel Intervention for Cannabis Use Problems?

NCT02044809 ↗

Phase 2 Completed 82 enrolled University College, London
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-03
Primary completion
2017-02-09
Completion
2017-06-05

Outcome

Met primary endpoint

paper At final analysis, cannabidiol 400 mg and 800 mg exceeded primary endpoint criteria (0·9) for both primary outcomes. PMID 32735782 ↗

paper Compared with placebo, cannabidiol 400 mg decreased THC-COOH:creatinine ratio by -94·21 ng/mL (95% interval estimate -161·83 to -35·56) and increased abstinence from cannabis by 0·48 days per week (0·15 to 0·82). PMID 32735782 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 200 mg Oral
Subject Cannabidiol Other / unclassified 400 mg Oral
Subject Cannabidiol Other / unclassified 800 mg Oral

Indications