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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034408
• Other study ID #: 2015-00160
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2016
• Est. completion date: December 17, 2018

Study information

• Verified date: October 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Impulsive Behavior

Intervention

Drug:
• Nalmefene

• Baclofen

• Placebo Oral Capsule

Locations

Country	Name	City	State
Switzerland	Service d'Addictologie, Hôpitaux Universitaires de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Daniele Zullino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   website related to the study