TY - JOUR
T1 - Clinical validation of reduction in cocaine frequency level as an endpoint in clinical trials for cocaine use disorder
AU - Roos, Corey R.
AU - Nich, Charla
AU - Mun, Chung Jung
AU - Babuscio, Theresa A.
AU - Mendonca, Justin
AU - Miguel, André Q.C.
AU - DeVito, Elise E.
AU - Yip, Sarah W.
AU - Witkiewitz, Katie
AU - Carroll, Kathleen M.
AU - Kiluk, Brian D.
N1 - Funding Information:
This research was supported by the following grants funded by the National Institute on Drug Abuse (NIDA) : R21DA041661 ; P50DA009241 ; T32DA007238-27 ; K01DA039299 ). NIDA had had no further role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.
Publisher Copyright:
© 2019 Elsevier B.V.
PY - 2019/12/1
Y1 - 2019/12/1
N2 - 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.
AB - 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.
KW - Cocaine use disorder
KW - Endpoints
KW - Harm reduction
KW - Non-Abstinence endpoints
KW - Reduction in cocaine use
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U2 - 10.1016/j.drugalcdep.2019.107648
DO - 10.1016/j.drugalcdep.2019.107648
M3 - Article
C2 - 31677490
AN - SCOPUS:85074176996
SN - 0376-8716
VL - 205
JO - Drug and alcohol dependence
JF - Drug and alcohol dependence
M1 - 107648
ER -