Evaluating the abuse potential of opioids and abuse-deterrent -opioid formulations: A review of clinical study methodology
| Autor: | Kerri A. Schoedel, Megan J. Shram, Naama Levy-Cooperman, Glenn C. Pixton, Carl L. Roland, Beatrice Setnik |
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| Rok vydání: | 2018 |
| Předmět: |
Research design
Blinding Research Subjects Substance-Related Disorders Best practice Chemistry Pharmaceutical Drug Compounding MEDLINE Abuse-Deterrent Formulations 030226 pharmacology & pharmacy Risk Assessment Drug Users 03 medical and health sciences 0302 clinical medicine Risk Factors Medicine Humans Pharmacology (medical) 030212 general & internal medicine Chemistry (relationship) Recreation business.industry Patient Selection Clinical Studies as Topic General Medicine Opioid-Related Disorders Analgesics Opioid Anesthesiology and Pain Medicine Research Design Opiate business Risk assessment Clinical psychology |
| Zdroj: | Journal of opioid management. 13(6) |
| ISSN: | 1551-7489 |
| Popis: | With the development of opioid abuse-deterrent formulations (ADFs), there is a need to conduct well-designed human abuse potential studies to evaluate the effectiveness of their deterrent properties. Although these types of studies have been conducted for many years, largely to evaluate inherent abuse potential of a molecule and inform drug scheduling, methodological approaches have varied across studies. The focus of this review is to describe current “best practices” and methodological adaptations required to assess abuse-deterrent opioid formulations for regulatory submissions. A literature search was conducted in PubMed® to review methodological approaches (study conduct and analysis) used in opioid human abuse potential studies. Search terms included a combination of “opioid,” “opiate,” “abuse potential,” “abuse liability,” “liking,” AND “pharmacodynamic,” and only studies that evaluated single doses of opioids in healthy, nondependent individuals with or without prior opioid experience were included. Seventy-one human abuse potential studies meeting the prespecified criteria were identified, of which 21 studies evaluated a purported opioid ADF. Based on these studies, key methodological considerations were reviewed and summarized according to participant demographics, study prequalification, comparator and dose selection, route of administration and drug manipulation, study blinding, outcome measures and training, safety, and statistical analyses. The authors recommend careful consideration of key elements (eg, a standardized definition of a “nondependent recreational user”), as applicable, and offer key principles and “best practices” when conducting human abuse potential studies for opioid ADFs. Careful selection of appropriate study conditions is dependent on the type of ADF technology being evaluated. |
| Databáze: | OpenAIRE |
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