@article{7dd156b7a97d40c69217ef8ef379c13b,
title = "The state of clinical outcome assessments for cannabis use disorder clinical trials: A review and research agenda",
abstract = "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.",
keywords = "CUD, Cannabis use disorder, Clinical outcome assessment, Clinical trial, Endpoints, Outcome measures",
author = "Loflin, {Mallory J.E.} and Kiluk, {Brian D.} and Huestis, {Marilyn A.} and Aklin, {Will M.} and Budney, {Alan J.} and Carroll, {Kathleen M.} and D'Souza, {Deepak Cyril} and Dworkin, {Robert H.} and Gray, {Kevin M.} and Hasin, {Deborah S.} and Lee, {Dustin C.} and {Le Foll}, Bernard and Levin, {Frances R.} and Lile, {Joshua A.} and Mason, {Barbara J.} and McRae-Clark, {Aimee L.} and Ivan Montoya and Peters, {Erica N.} and Tatiana Ramey and Turk, {Dennis C.} and Ryan Vandrey and Weiss, {Roger D.} and Strain, {Eric C.}",
note = "Funding Information: Meeting attendees who were not employed by the US government or industry received travel stipends, hotel accommodations, and meals during the meeting provided by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks ( ACTTION ) public-private partnership with the US Food and Drug Administration (FDA). ACTTION has received research contracts, grants, and other revenue from the FDA , multiple pharmaceutical and device companies, philanthropy, and other sources. Preparation of background literature reviews and draft manuscripts was supported by ACTTION. This article does not represent the official views of the authors{\textquoteright} affiliate institutes, the FDA, US National Institutes of Health, or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION. Funding Information: Author ES has served on advisory boards, received grant funding from, and/or consulted for: Alkermes, Analgesic Solutions, Caron, Egalet, Indivior Pharmaceuticals, Innocoll Pharmaceuticals, The Oak Group, Otsuka Pharmaceutical Development and Commercialization, and Pinney Associates. He has received honoraria from Medscape and the WHO. He is currently collaborating with Innovative Health Solutions, the makers of the Bridge Device. Funding Information: Meeting attendees who were not employed by the US government or industry received travel stipends, hotel accommodations, and meals during the meeting provided by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA). ACTTION has received research contracts, grants, and other revenue from the FDA, multiple pharmaceutical and device companies, philanthropy, and other sources. Preparation of background literature reviews and draft manuscripts was supported by ACTTION. This article does not represent the official views of the authors? affiliate institutes, the FDA, US National Institutes of Health, or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION. Publisher Copyright: {\textcopyright} 2020 Elsevier B.V.",
year = "2020",
month = jul,
day = "1",
doi = "10.1016/j.drugalcdep.2020.107993",
language = "English (US)",
volume = "212",
journal = "Drug and alcohol dependence",
issn = "0376-8716",
publisher = "Elsevier Ireland Ltd",
}