Cannabinoid Agonist Oral Spray Nabiximols Modestly Reduces Cannabis Use

Cannabis use and use disorder are common and increasing. There is no effective pharmacologic treatment for cannabis use disorder and a previous trial of dronabinol, an oral synthetic tetrahydrocannabinol (THC) product, failed to show a significant impact on cannabis use. Nabiximols is a combination of THC and cannabidiol (CBD) delivered as an oral spray. In this 12-week study conducted in Australia, 128 volunteers with ICD-10 cannabis dependence were randomized to receive either placebo spray or nabiximols; dosing was flexible—up to 32 sprays/day, which in the nabiximols group would deliver 86 mg of THC.

• Treatment retention was similar in both arms: 49% of those assigned to nabiximols and 47% assigned to placebo.
• The nabiximols group reported fewer days of cannabis use over the 84-day trial: a mean of 35 days versus 53 days in the placebo group.
• Measures of cannabis-related problems, withdrawal, and craving improved in both groups, without significant differences between the two. Nabiximols had few side effects and 75% of those who received placebo and 82% of those who received nabiximols said they would recommend the medication to a friend seeking treatment.

Comments: This study shows that this THC/CBD spray leads to a modest reduction in self-reported days of cannabis use among treatment-seeking individuals with ICD-10 cannabis dependence. The possible reasons why this medication was modestly effective while dronabinol was not include the delivery system, flexible dosing, and the combination of CBD with THC. It remains to be seen whether this treatment improves clinical or functional outcomes.

Darius A. Rastegar, MD

Reference: Lintzeris N, Bhardwaj A, Mills L, et al. Nabiximols for the treatment of cannabis dependence: a randomized clinical trial. JAMA Intern Med. 2019 [Epub ahead of print]. doi: 10.1001/jamainternmed.2019.1993.