TY - JOUR
T1 - Measures of outcome for stimulant trials
T2 - ACTTION recommendations and research agenda
AU - Kiluk, Brian D.
AU - Carroll, Kathleen M.
AU - Duhig, Amy
AU - Falk, Daniel E.
AU - Kampman, Kyle
AU - Lai, Shengan
AU - Litten, Raye Z.
AU - McCann, David J.
AU - Montoya, Ivan D.
AU - Preston, Kenzie L.
AU - Skolnick, Phil
AU - Weisner, Constance
AU - Woody, George
AU - Chandler, Redonna
AU - Detke, Michael J.
AU - Dunn, Kelly
AU - Dworkin, Robert H.
AU - Fertig, Joanne
AU - Gewandter, Jennifer
AU - Moeller, F. Gerard
AU - Ramey, Tatiana
AU - Ryan, Megan
AU - Silverman, Kenneth
AU - Strain, Eric C.
N1 - Funding Information:
The views expressed in this article are those of the authors, none of whom have financial conflicts of interest specifically related to the issues discussed in this article. At the time of the meeting on which this article is based, several authors were employed by pharmaceutical companies and others had received consulting fees or honoraria from one or more pharmaceutical or device companies. Authors of this article who were not employed by industry or government at the time of the meeting 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), which has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, and other sources. Preparation of background literature reviews and draft manuscripts was supported by ACTTION. No official endorsement by the FDA, US National Institutes of Health, or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of ACTTION should be inferred.
Funding Information:
The work of authors who are NIH Intramural staff was supported in part by the NIDA Intramural Research Program. The work of authors Kiluk and Carroll was supported in part by NIDA grant P50-DA09241 (Carroll, PI). Author Strain was supported in part by NIDA grant K24-DA023186 . The funding sources had no further role in the writing of this report.
Publisher Copyright:
© 2015 Elsevier Ireland Ltd.
PY - 2016/1/1
Y1 - 2016/1/1
N2 - Background: The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. Methods: In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Results and conclusions: Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success.
AB - Background: The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. Methods: In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Results and conclusions: Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success.
KW - Clinical trials
KW - Outcome measures
KW - Stimulant use disorders
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U2 - 10.1016/j.drugalcdep.2015.11.004
DO - 10.1016/j.drugalcdep.2015.11.004
M3 - Review article
C2 - 26652899
AN - SCOPUS:84951791233
SN - 0376-8716
VL - 158
SP - 1
EP - 7
JO - Drug and Alcohol Dependence
JF - Drug and Alcohol Dependence
ER -