Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity (NALCUE)

June 28, 2017 updated by: Central Institute of Mental Health, Mannheim

Nalmefene Challenge to Modulate Neural Reactivity to Alcohol-related and Emotional Cues in Non-treatment Seeking Alcohol Dependent Participants

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

All subjects will undergo a battery of minimal risk procedures during each study visit; filling out questionnaires, performing agreed behavioral tasks, scanning procedures including two functional MRI (fMRI) scans as well as structural MRI.

The fMRI will be obtained in non-abstinent participants with breath alcohol concentrations not larger than > 0.3 ‰ and withdrawal severity not more than 4 on the clinical institute withdrawal assessment for alcohol (CIWA-Ar) scale.

Alcohol consumption will be assessed with the Form90 interview. Severity of alcohol dependence will be examined with the Alcohol Dependence Scale (ADS). Drinking situations will be assessed with the Inventory of Drinking Situations (IDS). Trait aspects of craving for alcohol will be measured with the Obsessive Compulsive Drinking Scale (OCDS). To examine state and trait anxiety the State-Trait Anxiety Inventory (STAI) will be used. Depressive symptoms will be measured with the Beck Depression Inventory (BDI) and the State-Trait Depression Scales (STDS). Nicotine consumption will be assessed with the Fagerström Test for Nicotine Dependence.

The following scales will be administered before and after each fMRI scanning: The Alcohol Craving Questionnaire (ACQ), the Alcohol Urge Questionaire (AUQ) and visual analogue scales for craving assessment.

Participants will undergo two fMRI scanning sessions at intervals of one week: one 2 h after administration of nalmefene and one 2 h after administration of placebo, carried out in a randomized order.

MRI examinations include

  • a cue-reactivity task;
  • an emotional faces task;
  • resting-state fMRI;
  • structural MRI;
  • including preparation, instructions and breaks

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68167
        • Zentralinstitut für seelische Gesundheit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nalmefene Challenge
Participants will receive 18mg Nalmefene two hours prior to fMRI measurement. During fMRI scanning alcohol cues will be presented.
Drug: Nalmefene
18mg of Nalmefen will be administered orally
Other Names:
  • Selincro
Placebo Comparator: Placebo
Participants will receive Placebo two hours prior to fMRI measurement. During fMRI scanning alcohol cues will be presented.
Drug: Placebo
Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in cue-induced brain activation between two fMRI scans (randomization to an intake of nalmefene (18 mg) or placebo).
Time Frame: Primary outcome measures will be assessed on day 2 and day3 after fMRI scan, data collection will take up to 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

Lundbeck GmbH, Ericusspitze 2, 20457 Hamburg

Investigators

  • Principal Investigator: Falk Kiefer, Prof. Dr., Central Institute of Mental Health, Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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