Alcohol Use Disorder
Conditions
Keywords
Impulsivity, Nalmefene, Baclofen
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
Interventions
Sponsors
Prof. Daniele Zullino
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Outcome results
None listed