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Injectable extended‐release naltrexone ( XR ‐ NTX ) for opioid dependence: long‐term safety and effectiveness
Author(s) -
Krupitsky Evgeny,
Nunes Edward V.,
Ling Walter,
Gastfriend David R.,
Memisoglu Asli,
Silverman Bernard L.
Publication year - 2013
Publication title -
addiction
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.424
H-Index - 193
eISSN - 1360-0443
pISSN - 0965-2140
DOI - 10.1111/add.12208
Subject(s) - naltrexone , discontinuation , medicine , adverse effect , placebo , open label , opioid , anesthesia , alternative medicine , receptor , pathology
Aims To describe drug use and safety with intramuscular injectable extended‐release naltrexone ( XR ‐ NTX ) in opioid dependence during a 1‐year open‐label extension phase. Design Following 6 months of randomized, double‐blind, placebo (PBO)‐controlled injections given every 28 days, patients receiving XR ‐ NTX 380 mg continued and PBO patients were switched to open‐label XR ‐ NTX , with monthly individual drug counseling, for a further year. Setting Thirteen clinical sites in R ussia. Participants Adult opioid‐dependent outpatients. Measurements Monthly urine samples; reports of craving and functioning; adverse events. Findings For the open‐label extension ( n = 114), 67 continued on XR ‐ NTX and 47 switched from PBO during the double‐blind phase to XR ‐ NTX during the open‐label phase. Overall, 62.3% (95% CI : 52.7%, 71.2%) completed the extension. Discontinuation occurred most commonly because of withdrawal of consent (18.4%) and loss to follow‐up (11.4%); two patients discontinued as a result of lack of efficacy and one because of adverse events. Urine testing revealed that 50.9% (41.5%, 60.4%) were abstinent from opioids at all assessments during the 1‐year open‐label phase. Adverse events reported by 21.1% of patients were judged to be study drug‐related. Injection site reactions were infrequent (6.1%) and the majority were mild. Elevations in liver function tests occurred for 16.7% of patients, but none of these elevations was judged to be clinically significant. No patients died, overdosed or discontinued as a result of severe adverse events. Conclusions During a 1‐year open‐label extension phase of injectable XR ‐ NTX for the prevention of relapse in opioid dependence, 62.3% of patients completed the phase and 50.9% were abstinent from opioids. No new safety concerns were evident.