Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects
Status:
Completed
Trial end date:
2018-12-17
Target enrollment:
Participant gender:
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