PMID- 24107112
OWN - NLM
STAT- MEDLINE
DCOM- 20151022
LR  - 20161020
IS  - 1521-0391 (Electronic)
IS  - 1055-0496 (Linking)
VI  - 23
IP  - 2
DP  - 2014 Mar-Apr
TI  - Phase I study of injectable, depot naltrexone for the relapse prevention 
      treatment of opioid dependence.
PG  - 162-9
LID - 10.1111/j.1521-0391.2013.12085.x [doi]
AB  - BACKGROUND AND OBJECTIVES: We tested long-acting injectable depot naltrexone for 
      its tolerability, pharmacokinetics, and safety in Phase I. METHODS: The Phase I 
      trial enrolled 36 healthy participants in two panels (A, B). In Panel A, 24 
      subjects were randomly assigned to the high-dosage group (400 mg naltrexone, n=6; 
      placebo, n=6) or low-dosage group (200 mg naltrexone, n=6; placebo, n=6). In 
      Panel B, 12 subjects were randomized to take six doses of monthly injectable 
      naltrexone (400 mg) or placebo. RESULTS: After a single injection of naltrexone 
      200 and 400 mg, means (SD) of naltrexone plasma concentrations were .57 
      (.28) ng/ml and 1.5 (.8) ng/ml 30 days post-injection. There was no effect of 
      accumulation after multiple dosing. Eleven of 30 subjects (36.67%) who were 
      administered injectable depot naltrexone reported a total of 12 adverse events 
      (AEs). Seven of these 11 AEs were coded as possibly related with study 
      medication. All treatment-related AEs were mild in severity. No serious 
      treatment-related AEs occurred. DISCUSSION AND CONCLUSIONS: This long-acting 
      formulation of injectable depot naltrexone is well tolerated, results in constant 
      plasma concentration of naltrexone for at least 1 month. SCIENTIFIC SIGNIFICANCE: 
      The tolerability and safety of long-acting injectable depot naltrexone are good.
CI  - Copyright (c) American Academy of Addiction Psychiatry.
FAU - Xuyi, Wang
AU  - Xuyi W
AD  - Mental Health Institute of the Second Xiangya Hospital, Central South University, 
      Changsha, Hunan, China.
FAU - Juelu, Wang
AU  - Juelu W
FAU - Xiaojun, Xiang
AU  - Xiaojun X
FAU - Haiyan, Li
AU  - Haiyan L
FAU - Zheyuan, Liu
AU  - Zheyuan L
FAU - Zhehui, Gong
AU  - Zhehui G
FAU - Guoming, Dong
AU  - Guoming D
FAU - Gang, Liu
AU  - Gang L
FAU - Jin, Li
AU  - Jin L
FAU - Wei, Hao
AU  - Wei H
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130920
PL  - England
TA  - Am J Addict
JT  - The American journal on addictions
JID - 9208821
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Narcotic Antagonists)
RN  - 5S6W795CQM (Naltrexone)
SB  - IM
MH  - Adult
MH  - Delayed-Action Preparations/administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections
MH  - Male
MH  - Naltrexone/*administration & dosage/adverse effects/blood/*pharmacokinetics
MH  - Narcotic Antagonists/administration & dosage/adverse effects/blood
MH  - Opioid-Related Disorders/*prevention & control
MH  - *Secondary Prevention
MH  - Young Adult
EDAT- 2013/10/11 06:00
MHDA- 2015/10/23 06:00
CRDT- 2013/10/11 06:00
PHST- 2012/10/26 00:00 [received]
PHST- 2013/03/27 00:00 [revised]
PHST- 2013/03/31 00:00 [accepted]
PHST- 2013/10/11 06:00 [entrez]
PHST- 2013/10/11 06:00 [pubmed]
PHST- 2015/10/23 06:00 [medline]
AID - 10.1111/j.1521-0391.2013.12085.x [doi]
PST - ppublish
SO  - Am J Addict. 2014 Mar-Apr;23(2):162-9. doi: 10.1111/j.1521-0391.2013.12085.x. 
      Epub 2013 Sep 20.