Improving Translational Research Outcomes for Opioid Use Disorder Treatments.

Autor: Jones JD; Division on Substance Use Disorders, Department of Psychiatry, New York State Psychiatric Institute, and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, USA., Varshneya NB; Department of Pharmacology and Toxicology, Virginia Commonwealth University School of Medicine, 410 N 12th St, Richmond, VA 23298, USA.; Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA., Hudzik TJ; In Vitro In Vivo Translation, NonClinical Safety, GlaxoSmithKline, 1250 S. Collegeville Road, Collegeville, PA 19426, USA., Huhn AS; Behavioral Pharmacology Research Unit, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.
Jazyk: angličtina
Zdroj: Current addiction reports [Curr Addict Rep] 2021 Mar; Vol. 8 (1), pp. 109-121. Date of Electronic Publication: 2021 Jan 12.
DOI: 10.1007/s40429-020-00353-5
Abstrakt: Purpose of Review: Pharmacotherapies are the most effective means of reducing the harms associated with opioid use disorder (OUD). Translational research seeking to develop novel medications to treat OUD has been challenging due to the complex etiology of addiction. Preclinical outcome measures are often behavioral, and it is difficult, if not impossible, to fully mirror the various emotional and cognitive processes that motivate opioid use in humans. The goal of the current narrative review was to summarize the translational progression of three potential medications for OUD, which had varying levels of success.
Recent Findings: Memantine, lorcaserin, and lofexidine all showed promise in preclinical studies; however, only lofexidine was able to consistently replicate these findings in human subjects, and receive FDA approval. It was the authors' objective to use this review to identify areas of needed improvement in translational research for OUD.
Summary: Preclinical studies vary significantly in their ability to forecast effectiveness in clinical trials. Among the various preclinical models, suppression of opioid self-administration appears to have the best predictive validity. As they model a mostly physiological phenomenon, preclinical assessments of opioid withdrawal also appear to have high predictive validity. In our review of the literature, the authors noted numerous examples of clinical trials that were underpowered, lack precision, and proper outcomes. Better-validated preclinical targets and improved design of proof-of-concept human studies should allow investigators to more efficiently develop and test medications for OUD.
Databáze: MEDLINE
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