ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults

Summary

This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal increases in response to alcohol-related cues. In the double-blind portion, subjects received a single administration of study drug (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg.

Timeline

Start

2007-07

Primary completion

2009-06

Completion

2009-10

Outcome

Mixed primary results

registry analysis (superiority or other test); VIVITROL 380 mg vs Placebo; p <0.00002; t-test, 1 sided NCT00511836 ↗

registry analysis (superiority or other test); VIVITROL 380 mg vs Placebo; p = 0.245; t-test, 1 sided NCT00511836 ↗

Publications

• Results Lukas SE, Lowen SB, Lindsey KP, Conn N, Tartarini W, Rodolico J, Mallya G, Palmer C, Penetar DM. Extended-release naltrexone (XR-NTX) attenuates brain responses to alcohol cues in alcohol-dependent volunteers: a bold FMRI study. Neuroimage. 2013 Sep;78:176-85. doi: 10.1016/j.neuroimage.2013.03.055. Epub 2013 Apr 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	380 mg	Intramuscular

Indications