Evaluation of opioid withdrawal after maintenance on extended-release tramadol

Abstract

s / Drug and Alcohol Dependence 140 (2014) e86–e168 e163 motivational interventionmaybe sufficient for substantially reducing unmotivated, non-treatment seeking individuals use of ecstasy. Financial support: Australian Government Department of Health and Ageing under the National Psychostimulants Initiative. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.458 Opioid substitution treatment enrollment and outcomes in California: 1991–2011 Bohdan Nosyk1,2, E. Evans2, Libo Li2, Darren Urada2, M.J. Milloy1, Evan Wood1, R. Rawson2, Y. Hser2 1 BC Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada 2 UCLA Integrated Substance Abuse Programs, Los Angeles, CA, United States Aims: To provide a descriptive analysis of the opioid substitution treatment (OST) delivery system, we examine trends in demographic anddrug use characteristics of patients accessingOST in California over the past 20 years. Methods: Statewide administrative datawas obtained from the California Alcohol & Drug Data System (CADDS; 1991–2005) and CaliforniaOutcomeMeasurementSystem(CalOMS;2006–2011)on all patients admitted to publicly funded OST programs from 1991 to 2011. Univariate trends in demographic, drug use characteristics and treatment outcomes were considered. Cochran-Armitage tests were applied to confirm observed trends. Results: The study sample consisted of 240,225 individuals and 689,192 treatment episodes. Individuals had amedian 2 (IQR: 1–5) OST episodes during the study period. The annual number of new OST admissions peaked in 1994 (51,902) and fell to 18,480 in 2011; within these years, detoxification treatment admissions fell from 88.0% to 41.4% (p 20 of the last 30 days, and meeting DSM-IV criteria for current opioid dependence with observed withdrawal. After random assignment to ER tramadol (0, 100 or 300mg bid for 7 days; n=12/group), all groups crossed over to placebo for 6 additional days of monitoring. Four breakthrough withdrawal medications were available. Primary outcomes were: (1) number of breakthrough withdrawal medication doses taken and (2) subject-rated opioid withdrawal. Secondary outcomes included observer-rated withdrawal ratings, physiologic and cognitive measures, and serious adverse events. Results: Amount of breakthrough withdrawal medication differed significantly among groups (p<0.001) over the 6-day placebo-dosing period whereby the 600mg tramadol group requested significantly more rescue doses on days 2–4 (Dunnet p<0.05) versus the placebo-assigned group. Specifically, more acetaminophenwasused in the600mg transfer group thanplacebo ondays2–4 (Dunnetp<0.05). Therewerenostatistically significant increases on subject-rated withdrawal measures. Observer-rated withdrawal scores for the 600mg group increased modestly from days 2–3 and then decreased to values similar to the 200mg and placebo groups. There were no serious adverse events. Conclusions: Abrupt cessation of repeated dosing with ER tramadol 600, but not 200mg, produced opioid withdrawal as evidenced primarily by increased use of rescue medications. Financial support: NIDA R01 DA027068 (MRL), T32 DA007304 and NCRR and NCATS UL1RR033173. http://dx.doi.org/10.1016/j.drugalcdep.2014.02.460