Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol Use Disorder | Other | 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 | Other | 30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalmefene | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in "Average number of pumps" delivered in the Balloon Analogue Risk Task |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniele F Zullino, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Addictologie, Hôpitaux Universitaires de Genève | Geneva | 1202 | Switzerland |
Not provided
| Label | URL |
|---|---|
| website related to the study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C038981 | nalmefene |
| D001418 | Baclofen |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baclofen |
| Drug |
|
|
| Placebo Oral Capsule | Drug |
|
|
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 |
| D001519 | Behavior |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D002241 | Carbohydrates |