Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Study Overview
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Brief Summary
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Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on impulsivity. Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control subjects. Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk taking (as measured by the Balloon Analogue Risk Task) and on the preference for small immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To compare subjects with alcohol use disorder and healthy control subjects on these tasks. Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps delivered in the Balloon Analogue Risk Task Study Design: Randomized, placebo control, cross-over, single-dose

Official Title
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Effects of Nalmefene and Baclofen on Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects: A Randomized, Placebo-controlled Study

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Nalmefene
* Drug: Baclofen
* Drug: Placebo Oral Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20), 30 sex and age-matched healthy controls, over 18, informed consent. Exclusion Criteria: opiate-treatment, contra-indications for Nalmefene and/or Baclofen, unstable psychiatric disorder, pregnancy, acute withdrawal syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Alcohol Use Disorder<br>30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule | Drug: Nalmefene<br> <br> * Other names: Selincro;Drug: Baclofen<br> <br> * Other names: Lioresal;Drug: Placebo Oral Capsule<br> <br> * Other names: Mannitol;|
| Other: Healthy Control<br>30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule | Drug: Nalmefene<br> <br> * Other names: Selincro;Drug: Baclofen<br> <br> * Other names: Lioresal;Drug: Placebo Oral Capsule<br> <br> * Other names: Mannitol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stop-signal reaction time in the Stop-Signal Task | Before-drug/after-drug difference of the stop-signal reaction time in the Stop Signal Task at Visit 2, Visit 3 and Visit 4. | 0 and 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Equivalence point in the Delay-Discounting Task | Before-drug/after-drug difference of the Equivalence point in the Delay-Discounting Task at Visit 2, Visit 3 and Visit 4. | 0 and 2 hours post-dose | 
| Change in Average number of pumps delivered in the Balloon Analogue Risk Task | Before-drug/after-drug difference of the Average number of pumps delivered in the Balloon Analogue Risk Task at Visit 2, Visit 3 and Visit 4. | 0 and 2 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impulsivity, Nalmefene, Baclofen