Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Institute of Mental Health, Mannheim
• Collaborator: Lundbeck GmbH, Ericusspitze 2, 20457 Hamburg
• Treatments: Ethanol; Nalmefene; Naltrexone

Criteria

Inclusion Criteria:

• severe alcohol use disorder according to DSM 5 and "heavy drinking": alcohol consumption >=60g (men) and >=40g (women) (minimum of 5 days / week)

• right-handedness

• normal or corrected to normal vision

• signed written informed consent

Exclusion Criteria:

valid at the time of MRI investigation:

• psychotropic medication within the last 14 days

• severe withdrawal symptoms (CIWA-Ar > 4; Sullivan et al. 1989)

• intoxication (breath alcohol concentration > 0.3 ‰)

• common exclusion criteria for MRI (e.g. metal, claustrophobia)

• positive drug screening (opioids, cannabinoids, benzodiazepines, barbiturates, cocaine, amphetamines)

• pregnancy

• contraindications to the prescription of nalmefene valid at inclusion:

• previous severe withdrawal / withdrawal complications

• previous inpatient detoxification treatment

• other Axis I psychiatric diagnoses than alcohol- or nicotine-dependence in the last 12 months

• neurological disorders, history of brain injury