Clinical validation of reduction in cocaine frequency level as an endpoint in clinical trials for cocaine use disorder.

Autor: Roos CR; Yale University School of Medicine, New Haven, CT, United States. Electronic address: corey.roos@yale.edu., Nich C; Yale University School of Medicine, New Haven, CT, United States., Mun CJ; John Hopkins University School of Medicine, Baltimore, MD, United States., Babuscio TA; Yale University School of Medicine, New Haven, CT, United States., Mendonca J; Yale University School of Medicine, New Haven, CT, United States., Miguel AQC; Washington State University Elson S. Floyd College of Medicine, Washington, United States; Department of Psychiatry, Federal University of Sao Paulo, Sao Paulo, Brazil., DeVito EE; Yale University School of Medicine, New Haven, CT, United States., Yip SW; Yale University School of Medicine, New Haven, CT, United States., Witkiewitz K; Department of Psychology, University of New Mexico, Albuquerque, NM, United States., Carroll KM; Yale University School of Medicine, New Haven, CT, United States., Kiluk BD; Yale University School of Medicine, New Haven, CT, United States.
Jazyk: angličtina
Zdroj: Drug and alcohol dependence [Drug Alcohol Depend] 2019 Dec 01; Vol. 205, pp. 107648. Date of Electronic Publication: 2019 Oct 21.
DOI: 10.1016/j.drugalcdep.2019.107648
Abstrakt: Background: Despite calls for non-abstinence endpoints in randomized clinical trials (RCTs) for cocaine use disorder, there is a lack of data validating non-abstinence endpoints. We conducted a clinical validation of reduction in cocaine frequency level as a non-abstinence endpoint in RCTs for cocaine use disorder (CUD).
Methods: We utilized a pooled dataset (n = 716; 63.6 % male, 51.4 % non-Hispanic white) from seven RCTs for CUD. We specified three cocaine frequency levels at baseline and end of treatment (EOT): abstinence, low frequency (1-4 days/month), and high frequency (5+ days/month). Multiple regression analyses were conducted.
Results: Among the sample, 38.3 % had at least a one-level reduction from baseline to EOT, whereas 61.7 % did not change/increased frequency level. At least a one-level reduction in cocaine frequency level from baseline to EOT versus no change/increase was significantly associated with better functioning up to one year following treatment on measures of cocaine use, as well as psychological, employment, legal, and other drug use problem severity domains of the Addiction Severity Index (ASI). We also conducted analyses only among those at the high frequency level at baseline and found those who reduced to low frequency use at EOT had similar outcomes at follow-up as those who reduced to abstinence.
Conclusions: At least a one-level reduction in cocaine frequency level from pretreatment to EOT can be a clinically meaningful endpoint given its relation to sustained clinical benefit up to one-year following treatment. These data parallel recent findings regarding reduction in drinking risk level among individuals with alcohol use disorder.
(Copyright © 2019 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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