Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Alcohol Use Disorder 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
Other Names:
Drug: Baclofen
Other Names:
Drug: Placebo Oral Capsule
Other Names:
|
Other: Healthy Control 30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule |
Drug: Nalmefene
Other Names:
Drug: Baclofen
Other Names:
Drug: Placebo Oral Capsule
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20),
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30 sex and age-matched healthy controls,
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over 18, informed consent.
Exclusion Criteria:
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opiate-treatment,
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contra-indications for Nalmefene and/or Baclofen,
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unstable psychiatric disorder,
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pregnancy,
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acute withdrawal syndrome.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Service d'Addictologie, Hôpitaux Universitaires de Genève | Geneva | Switzerland | 1202 |
Sponsors and Collaborators
- Prof. Daniele Zullino
Investigators
- Principal Investigator: Daniele F Zullino, MD, University Hospital, Geneva
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2015-00160