Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

Phase 0 Terminated 23 enrolled Central Institute of Mental Health, Mannheim Lundbeck GmbH, Ericusspitze 2, 20457 Hamburg · collab

RandomizedCrossoverTriple-blindBasic science

Summary

The aim of this study is to use functional Magnetic Resonance Imaging (fMRI) to measure neural reactivity to alcohol-related and emotional cues in alcohol dependent subjects following a single dose of the opioid receptor modulator nalmefene. The study will be done in a cross over design with nalmefene versus placebo.

Timeline

Start: 2015-04
Primary completion: 2016-05
Completion: 2016-05

Outcome

Outcome not reported

Stopped (Enrollment): “Anticipated nr of 25 probands was not reached in terms of full data sets (missing data, low fMRI data quality), but time frame for recruitment ended.”

Publications

Grundinger N, Gerhardt S, Karl D, Mann K, Kiefer F, Vollstadt-Klein S. The effects of nalmefene on the impulsive and reflective system in alcohol use disorder: A resting-state fMRI study. Psychopharmacology (Berl). 2022 Aug;239(8):2471-2489. doi: 10.1007/s00213-022-06137-1. Epub 2022 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nalmefene	Small molecule	18 mg	Oral