NCT02372318

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 2, 2017

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

February 6, 2015

Last Update Submit

June 28, 2017

Conditions

Alcoholism

Keywords

opiod receptor modulator nalmefenecue-reactivityfMRIresting-state networks

Outcome Measures

Primary Outcomes (1)

  • Difference in cue-induced brain activation between two fMRI scans (randomization to an intake of nalmefene (18 mg) or placebo).

    This difference will be extracted from whole-brain contrast images in the VS and DS using the percentage of activated voxels in these regions of interest (ROI).

    Primary outcome measures will be assessed on day 2 and day3 after fMRI scan, data collection will take up to 12 months

Study Arms (2)

Nalmefene Challenge

EXPERIMENTAL

Participants will receive 18mg Nalmefene two hours prior to fMRI measurement. During fMRI scanning alcohol cues will be presented.

Drug: Nalmefene

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo two hours prior to fMRI measurement. During fMRI scanning alcohol cues will be presented.

Drug: Placebo

Interventions

NalmefeneDRUG

18mg of Nalmefen will be administered orally

Also known as: Selincro
Nalmefene Challenge
PlaceboDRUG

Placebo tablet

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentralinstitut für Seelische Gesundheit

Mannheim, 68167, Germany

Location

Related Publications (1)

  • 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.

    PMID: 35426492DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sabine Vollstädt-Klein, Prof. Dr.

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

  • Falk Kiefer, Prof. Dr.

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 26, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 2, 2017

Record last verified: 2016-01

Locations

DE(1)