The state of clinical outcome assessments for cannabis use disorder clinical trials: A review and research agenda

• Published in: Drug and alcohol dependence 2020-07, Vol.212, p.107993-107993, Article 107993
• Main Authors: Loflin, Mallory J.E., Kiluk, Brian D., Huestis, Marilyn A., Aklin, Will M., Budney, Alan J., Carroll, Kathleen M., D'Souza, Deepak Cyril, Dworkin, Robert H., Gray, Kevin M., Hasin, Deborah S., Lee, Dustin C., Le Foll, Bernard, Levin, Frances R., Lile, Joshua A., Mason, Barbara J., McRae-Clark, Aimee L., Montoya, Ivan, Peters, Erica N., Ramey, Tatiana, Turk, Dennis C., Vandrey, Ryan, Weiss, Roger D., Strain, Eric C.
• Format: Article
• Language: English
• Subjects: Adult; Assessments; Biomedical Research - methods; Cannabis; Cannabis use disorder; Clinical assessment; Clinical outcome assessment; Clinical outcomes; Clinical research; Clinical trial; Clinical trials; Clinical Trials as Topic - methods; CUD; Diagnostic systems; Drug addiction; Drug therapy; Endpoints; Female; Flexibility; Functional impairment; Humans; Male; Marijuana; Marijuana Abuse - epidemiology; Marijuana Abuse - therapy; Motivation; Outcome measures; Patient Outcome Assessment; Self Report; Toolkits
• ISSN: 0376-8716; 1879-0046
• DOI: 10.1016/j.drugalcdep.2020.107993

•Provides a review of clinical outcome assessments for CUD trial endpoints.•Abstinence is not the only valid indicator of CUD treatment success.•A core toolkit of assessments for CUD treatment studies is needed. There is considerable variability in the use of outcome measures in clinical trials for cannabis use disorder (CUD), and a lack of consensus regarding optimal outcomes may have hindered development and approval of new pharmacotherapies. The goal of this paper is to summarize an evaluation of assessment measures and clinical endpoints for CUD clinical trials, and propose a research agenda and priorities to improve CUD clinical outcome assessments. The primary recommendation is that sustained abstinence from cannabis should not be considered the primary outcome for all CUD clinical trials as it has multiple limitations. However, there are multiple challenges to the development of a reliable and valid indicator of cannabis reduction, including the lack of a standard unit of measure for the various forms of cannabis and products and the limitations of currently available biological and self-report assessments. Development of a core toolkit of assessments is needed to both allow flexibility for study design, while facilitating interpretation of outcomes across trials. Four primary agenda items for future research are identified to expedite development of improved clinical outcome assessments for this toolkit: (1) determine whether minimally invasive biologic assays could identify an acute level of cannabis use associated with psychomotor impairment or other cannabis-related harms; (2) create an indicator of quantity of cannabis use that is consistent across product types; (3) examine the presence of cannabis-specific functional outcomes; and (4) identify an optimal duration to assess changes in CUD diagnostic criteria.