Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nalmefene Challenge

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

Group Type EXPERIMENTAL

Nalmefene

Intervention Type DRUG

18mg of Nalmefen will be administered orally

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Interventions

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Nalmefene

18mg of Nalmefen will be administered orally

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Other Intervention Names

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Selincro

Eligibility Criteria

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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 ‰)
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No