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

Phase 2

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Nalmefene; Drug: Baclofen; Drug: Placebo Oral Capsule

• Registration Number: NCT03034408
• Lead Sponsor: Prof. Daniele Zullino

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Primary Completion: 2018-12-17
• Study Completion: 2018-12-17
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

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Exclusion Criteria

• opiate-treatment,
• contra-indications for Nalmefene and/or Baclofen,
• unstable psychiatric disorder,
• pregnancy,
• acute withdrawal syndrome.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Control	Nalmefene	30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Alcohol Use Disorder	Placebo Oral Capsule	30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Healthy Control	Placebo Oral Capsule	30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Healthy Control	Baclofen	30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Alcohol Use Disorder	Nalmefene	30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Alcohol Use Disorder	Baclofen	30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule

Primary Outcome Measures

Name	Time	Method
Change in "Stop-signal reaction time" in the Stop-Signal Task	0 and 2 hours post-dose	Before-drug/after-drug difference of the stop-signal reaction time in the Stop Signal Task at Visit 2, Visit 3 and Visit 4.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service d'Addictologie, Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland