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Review
. 2016 Jan 1:158:1-7.
doi: 10.1016/j.drugalcdep.2015.11.004. Epub 2015 Nov 21.

Measures of outcome for stimulant trials: ACTTION recommendations and research agenda

Brian D Kiluk  1 , Kathleen M Carroll  2 , Amy Duhig  3 , Daniel E Falk  4 , Kyle Kampman  5 , Shengan Lai  6 , Raye Z Litten  4 , David J McCann  7 , Ivan D Montoya  7 , Kenzie L Preston  7 , Phil Skolnick  7 , Constance Weisner  8 , George Woody  9 , Redonna Chandler  7 , Michael J Detke  10 , Kelly Dunn  6 , Robert H Dworkin  11 , Joanne Fertig  4 , Jennifer Gewandter  11 , F Gerard Moeller  12 , Tatiana Ramey  7 , Megan Ryan  4 , Kenneth Silverman  6 , Eric C Strain  6
Affiliations
Review

Measures of outcome for stimulant trials: ACTTION recommendations and research agenda

Brian D Kiluk et al. Drug Alcohol Depend. .

Abstract

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.

Keywords: Clinical trials; Outcome measures; Stimulant use disorders.

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Conflict of interest statement

Conflict of Interest

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.

Dr. Strain’s participation in this activity was as a consultant to ACTTION. All opinions expressed and implied in this activity are solely those of Dr. Strain and do not represent or reflect the views of the Johns Hopkins University or the Johns Hopkins Health System.

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