Daily oral therapy with cannabidiol 400 mg and 800 mg can safely and effectively treat cannabis use disorder, according to data published in Lancet Psychiatry.
Currently, cannabis use disorder affects about 22 million people worldwide. Over the past decade, the number of first-time addiction services clients citing cannabis as their primary drug has increased by 76% over the past decade. However, there are no recommended pharmacotherapies for cannabis use disorder.
A recent study out of the United Kingdom (ClinicalTrials.gov identifier NCT02044809) evaluated the safety and effectiveness of cannabidiol (CBD) for treating cannabis use disorder. CBD has been shown to reduce drug cravings in preclinical studies, suggesting it may have benefit in treating substance use disorders. Higher concentrations of Δ-9-tetrahydrocannabinol (THC), another component of cannabis, have been associated with an increased severity in cannabis use disorder.
This phase 2a, randomized, double-blind, placebo-controlled, parallel group clinical trial included participants aged 16 to 60 who met DSM-5 criteria for cannabis use disorder of at least moderate severity and who wanted to stop using the drug within the next month. The primary study endpoint was cannabis use measured via urine and patient self-report; secondary endpoints included reduced cannabis withdrawal symptoms, cigarette and alcohol consumption, urinary cotinine:creatinine ratio, depression and anxiety symptoms, and sleep quality.
For the first stage of the trial, participants (n=48) were randomly assigned to parallel treatment groups (1:1:1:1). Participants received either cannabidiol in 3 different daily doses (200 mg, 400 mg, or 800 mg) or a matched placebo. For the second stage of the trial, additional participants (n=34) were randomly assigned 1:1:1 to either receive a placebo or a dose of cannabidiol 400 mg or 800 mg, deemed beneficial during interim analysis.
After detailed analysis, researchers found that the 400 mg and 800 mg doses of cannabidiol to be more effective than placebo at reducing cannabis use. The number of mild and moderate adverse events did not vary significantly between the groups. No adverse events were recorded. Researchers found that participants achieved greater benefit from CBD than with the “brief psychological intervention typically delivered in drug treatment settings.”
The researchers concluded, “These findings are important in light of major policy changes surrounding the production and sale of cannabis products, increases in the number of people entering treatment for cannabis use disorders worldwide, and the absence of recommended pharmacotherapies at present.”
Disclosure: One study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Freeman TP, Hindocha C, Baio G, et al. Cannabidiol for the treatment of cannabis use disorder: A phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial [published online July 28, 2020]. Lancet Psychiatry. doi: 10.1016/S2215-0366(20)30290-X