Measures of outcome for stimulant trials: ACTTION recommendations and research agenda
| Autor: | Michael J. Detke, Constance Weisner, Tatiana Ramey, Eric C. Strain, Phil Skolnick, Robert H. Dworkin, Shengan Lai, Joanne B. Fertig, David J. McCann, Kenneth Silverman, Ivan D. Montoya, Raye Z. Litten, Megan L. Ryan, Brian D. Kiluk, Kyle M. Kampman, Jennifer S. Gewandter, Amy M. Duhig, Daniel E. Falk, Kelly E. Dunn, George E. Woody, Kathleen M. Carroll, F. Gerard Moeller, Kenzie L. Preston, Redonna K. Chandler |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Substance-Related Disorders media_common.quotation_subject Clinical Trials and Supportive Activities Amphetamine-Related Disorders 030508 substance abuse Toxicology Outcome measures Medical and Health Sciences Article Substance Misuse Alcohol Use and Health 03 medical and health sciences 0302 clinical medicine Clinical trials Clinical Research Health care Medicine Humans Pharmacology (medical) Psychiatry media_common Pharmacology Clinical Trials as Topic business.industry Operational definition Prevention Addiction Psychology and Cognitive Sciences Neurosciences Substance Abuse Abstinence Congresses as Topic Brain Disorders Clinical trial Stimulant use disorders Alcoholism Psychiatry and Mental health Good Health and Well Being Treatment Outcome Practice Guidelines as Topic Patient-reported outcome Central Nervous System Stimulants Drug Abuse (NIDA only) 0305 other medical science business Psychosocial 030217 neurology & neurosurgery |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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