and/or HIV infections. Krupitsky 1-yr Responses (2013) seen in the safety DB RCT and were effectiveness maintained observational during the extension extension study trial: 114 62.3% of patients patients from RCT who the continued on phase or were 50.9% switched were from PBO to abstinent ER-NTX from opioids No new safety concerns. Table Study Methods: Naltrexone ER Injection in Opioid Dependence Funding, Methods Participants Interventions Outcomes Quality, Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011 Apr 30;377(9776):1506-13. 24-wk, 18 yo; DSM-IV ER-NTX 380 POM: Sponsor: ≥ 13-site dx of opioid mg i.m. Confirmed Alkermes MC DB dependence; within 1 wk abstinence PC phase completing of detox response Moderate III RCT inpatient opioid then q4wk profiles (i.e., detoxification (≤ thereafter the Pts may have in 30 d); off opioids cumulative challenged PBO Russia for at least 7 d; percent of the tx and voluntarily seeking opioid-free 24 wk (6 been ITT, tx (not under weeks) injections) unblinded (pts LOCF. justice system during wks on PBO could Multiplicity Offered 12 coercion); 5–24; get high on correction biweekly supervised by confirmed opioids). Wks was used session of significant other to abstinence 1–4 were for individual adhere to study responders. prospectively craving drug procedures. Confirmed omitted from and counseling abstinence the POM. retention Primarily young was defined Results UDS for outcomes. (29 yo), male as a reflect the morphine (88%), white negative more stable and (99%), addicted to urine drug period of test and no abstinence
and/or HIV infections. Krupitsky (2013) 1-yr safety and effectiveness observational extension study 114 patients from RCT who continued on or were switched from PBO to ER-NTX Responses seen in the DB RCT were maintained during the extension trial: 62.3% of patients the phase 50.9% were abstinent from opioids No new safety concerns. Table Study Methods: Naltrexone ER Injection in Opioid Dependence Methods Participants Interventions Outcomes Funding, Quality, Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011 Apr 30;377(9776):1506-13. 24-wk, 13-site MC DB PC phase III RCT in Russia ITT, LOCF. Multiplicity correction was used for craving and retention outcomes. ≥ 18 yo; DSM-IV dx of opioid dependence; completing inpatient opioid detoxification (≤ 30 d); off opioids for at least 7 d; voluntarily seeking tx (not under justice system coercion); supervised by significant other to adhere to study procedures. Primarily young (29 yo), male (88%), white (99%), addicted to ER-NTX 380 mg i.m. within 1 wk of detox then q4wk thereafter PBO 24 wk (6 injections) Offered 12 biweekly session of individual drug counseling UDS for morphine and POM: Confirmed abstinence response profiles (i.e., the cumulative percent of opioid-free weeks) during wks 5–24; confirmed abstinence responders. Confirmed abstinence was defined as a negative urine drug test and no Sponsor: Alkermes Moderate Pts may have challenged the tx and been unblinded (pts on PBO could get high on opioids). Wks 1–4 were prospectively omitted from the POM. Results reflect the more stable period of abstinence
Naltrexone_ER_Susp_Inj_Monograph_Addendum_2014.docx