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Comment & Response
January 2020

Clinical Significance and Outcomes in Trial of Nabiximols for Treatment of Cannabis Dependence

Author Affiliations
  • 1Department of Psychiatry, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York
JAMA Intern Med. 2020;180(1):162-163. doi:10.1001/jamainternmed.2019.5664

To the Editor We read with interest the recently published randomized clinical trial by Lintzeris and colleagues1 reporting that use of nabiximols was superior to placebo in reducing days of cannabis use. To date, there are no US Food and Drug Administration–approved medications for the treatment of cannabis use disorder, and novel interventions are sorely needed. The authors state that the study findings are clinically significant because there were fewer days of use in the nabiximols arm compared with the placebo arm (ie, a mean difference of 18.6 days over the study period). However, the substantiation of this assertion is not provided. Based on the data presented, the nabiximols group averaged 4.4 d/wk and the placebo group averaged 2.9 d/wk during the trial. As noted by the authors, the 2 groups did not differ at the end of study in measured health or psychosocial outcomes. This finding illustrates a dilemma that the field finds itself in with regard to nonabstinence outcomes: what degree of cannabis use reduction is clinically meaningful if there is no measured change in health or quality of life? As noted by Lee and colleagues2 there have been numerous primary outcomes employed in marijuana pharmacologic treatment trials, but short of abstinence, there is not a consensus on what that clinically meaningful outcome would be.

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