Safety and pharmacokinetics of oxycodone DETERx administered intranasally in recreational opioid users

Abstract

s / Drug and Alcohol Dependence 146 (2015) e118–e201 e163 middle school students described parental disapproval as a deterrent, high school students also cited friend disapproval as deterring use. Across all groups, thosewhohad not tried e-cigs described lack of “coolness” as an additional deterrent. Conclusions: This qualitative study indicated several reasons why youth initiated, abstained from and discontinued e-cigarettes. While there were some common themes across groups, different themes also emerged across the age groups. Understanding these factors may inform e-cig prevention messages. Financial Support: This work was supported by the National Institute on Drug Abuse grant P50DA009241. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.359 Safety and pharmacokinetics of oxycodone DETERx administered intranasally in recreational opioid users A. Kopecky1, Alison B. Fleming1, Patrick K. Noonan2 1 Collegium Pharmaceutical, Inc., Canton, MA, United States 2 PK Noonan Pharmaceutical Consulting, LLC, Williamsburg, VA, United States Aims: Oxycodone DETERx is a multi-particulate, abusedeterrent formulation designed to retain ER properties following common methods of tampering. The purpose of this study was to assess the safety and the pharmacokinetics (PK) of crushed DETERx capsule contents administered IN (DETERx IN) compared with 2 control treatments: immediate-release (IR) oxycodone powder administered IN (Oxy IN) and intact DETERx capsules administered orally (DETERx PO). Methods: Open-label, randomized, naltrexone-blocked, 3treatment, 3-period, crossover comparison study. Safety and PK of 40mg doses of DETERx IN, Oxy IN, and DETERx PO were compared innondependent, recreational opioid users experiencedwith IN administration (n=13). DETERx capsule contents were crushed using themost aggressive crushingmethod identified in previously conducted studies. Plasma samples were collected at pre-specified time points and analyzed using a LC–MS/MS method. PK parameters Cmax, AUCINF, TmaxandAbuseQuotient (AQ)were calculated. Safety assessments included treatment-emergent adverse events, vital signs, oxygen saturation and nasal cavity assessments. Results: Cmax LSMean ratio for DETERx IN relative to Oxy IN was 59.0%. Cmax LSMean ratio for DETERx IN relative to DETERx PO was 79.6%. DETERx IN and DETERx PO both had a median Tmax of 5.0h, longer than Oxy IN (3.0h). Oxy IN had the highest AQ value (42.5ng/ml/h); AQ values for DETERx IN and DETERx POwere similar (8.5 and 8.4ng/ml/h, respectively). AUCINF values were similar for all treatments. There weremore spontaneously reported nasalrelated AEs and a greater number of episodes of need to blow nose post insulation of crushed DETERx compared with Oxy. Conclusions: Crushing and snorting DETERx capsule contents produces relatively lower plasma concentrations of oxycodone compared with intact DETERx PO and Oxy IN, indicating that a concentration driven euphoric effect sought by drug abusers may not be achieved. Due to the higher number of nasal-related AEs, abusers may find DETERx less desirable. Financial Support: Collegium Pharmaceutical. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.360 A novel behavioral activation intervention for smoking cessation; mechanisms of change Catalina Kopetz1, Laura MacPherson2, Avery Mitchell 2, Alexandra HoustonLudlam2, Reinout W. Wiers3, Helle Larsen3 1 Psychology, Wayne State University, Detroit, MI, United States 2 Psychology, University of Maryland, College Park, MD, United States 3 Psychology, University of Amsterdam, Amsterdam,