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NCT03102918: CBD

Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

Completed Phase 1 Results posted Last updated 25 January 2019
What this trial tests

Phase 1 trial testing Cannabidiol in Cannabis Use Disorder in 10 participants. Completed in 30 August 2017.

Timeline
20 February 2016
Primary endpoint
30 August 2017
30 August 2017

Quick facts

Lead sponsorMclean Hospital
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment10
Start date20 February 2016
Primary completion30 August 2017
Estimated completion30 August 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mclean Hospital

Who can join

Adults 18 to 65, any sex, with Cannabis Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-report Instruments to Measure Cannabis Use Primary · During Week 6

Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback

GroupValue95% CI
Cannabidiol26.72± 26.96
Placebo5.256± 4.34

Sponsor's own description

Investigators aim to determine Epidiolex's promise as a pharmacotherapy for cannabis use disorder. Investigators hypothesize that Epidiolex, when added to medical management, will result in greater reductions in marijuana use compared to placebo as measured by the 2 primary outcome measures: 1) quantitative THC levels and 2) self-report by Timeline Follow Back. Secondary outcome measures will include treatment retention, patient satisfaction, cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, , compliance, and cigarette use.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials.
    Chesney E, Oliver D, Green A, Sovi S, et al · · 2020 · cited 201× · PMID 32268347 · DOI 10.1038/s41386-020-0667-2
  2. Role of Cannabidiol in the Therapeutic Intervention for Substance Use Disorders.
    Navarrete F, García-Gutiérrez MS, Gasparyan A, Austrich-Olivares A, et al · · 2021 · cited 48× · PMID 34093179 · DOI 10.3389/fphar.2021.626010
  3. Cannabidiol regulates behavioural alterations and gene expression changes induced by spontaneous cannabinoid withdrawal.
    Navarrete F, Aracil-Fernández A, Manzanares J. · · 2018 · cited 25× · PMID 29624642 · DOI 10.1111/bph.14226
  4. Efficacy of Cannabidiol for Δ-9-Tetrahydrocannabinol-Induced Psychotic Symptoms, Schizophrenia, and Cannabis Use Disorders: A Narrative Review.
    Bartoli F, Riboldi I, Bachi B, Calabrese A, et al · · 2021 · cited 8× · PMID 33810033 · DOI 10.3390/jcm10061303

Verify or expand the search:

Other trials of Cannabidiol

Trials testing the same drug.

Other recruiting trials for Cannabis Use Disorder

Currently open trials in the same condition.

Other Mclean Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03102918.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing