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Browsing by Author "Strain, Eric C."
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Item Measures of outcome for stimulant trials: ACTTION recommendations and research agenda(Elsevier, 2016-01-01) Kiluk, Brian D.; Carroll, Kathleen M.; Duhig, Amy; Falk, Daniel E.; Kampman, Kyle; Lai, Shengan; Litten, Raye Z.; McCann, David J.; Montoya, Ivan D.; Preston, Kenzie L.; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J.; Dunn, Kelly; Dworkin, Robert H.; Fertig, Joanne; Gewandter, Jennifer; Moeller, F. Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C.; Department of Psychiatry, IU School of MedicineBACKGROUND: 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.Item Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations(International Association for the Study of Pain, 2021) Gewandter, Jennifer S.; Smith, Shannon M.; Dworkin, Robert H.; Turk, Dennis C.; Gan, Tong Joo; Gilron, Ian; Hertz, Sharon; Katz, Nathaniel P.; Markman, John D.; Raja, Srinivasa N.; Rowbotham, Michael C.; Stacey, Brett R.; Strain, Eric C.; Ward, Denham S.; Farrar, John T.; Kroenke, Kurt; Rathmell, James P.; Rauck, Richard; Brown, Colville; Cowan, Penney; Edwards, Robert R.; Eisenach, James C.; Ferguson, McKenzie; Freeman, Roy; Gray, Roy; Giblin, Kathryn; Grol-Prokopczyk, Hanna; Haythornthwaite, Jennifer; Jamison, Robert N.; Martel, Marc; McNicol, Ewan; Oshinsky, Michael; Sandbrink, Friedhelm; Scholz, Joachim; Scranton, Richard; Simon, Lee S.; Steiner, Deborah; Verburg, Kenneth; Wasan, Ajay D.; Wentworth, Kerry; Medicine, School of MedicineRandomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.