Phase I study of injectable, depot naltrexone for the relapse prevention treatment of opioid dependence
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...
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Published in | The American journal on addictions Vol. 23; no. 2; pp. 162 - 169 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Blackwell Publishing Ltd
01.03.2014
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Subjects | |
Online Access | Get full text |
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Summary: | 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. (Am J Addict 2014;23:162–169) |
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Bibliography: | ark:/67375/WNG-6DVW8X08-G National Key Basic Research and Development Program (NKBRDP) of China - No. 2009CB522000 ArticleID:AJAD12085 National Nature Science Foundation - No. 30971050 istex:68B073FA11E34F06600494B3D9A503451BA4669C ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-News-3 |
ISSN: | 1055-0496 1521-0391 |
DOI: | 10.1111/j.1521-0391.2013.12085.x |