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.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
Levin FR, Mariani JJ. Clinical Significance and Outcomes in Trial of Nabiximols for Treatment of Cannabis Dependence. JAMA Intern Med. 2020;180(1):162–163. doi:10.1001/jamainternmed.2019.5664
Coronavirus Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: