Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Nalmefene
Baclofen
Placebo Oral Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Impulsivity, Nalmefene, Baclofen
Eligibility Criteria
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.
Sites / Locations
- Service d'Addictologie, Hôpitaux Universitaires de Genève
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Alcohol Use Disorder
Healthy Control
Arm Description
30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03034408
First Posted
November 3, 2016
Last Updated
October 28, 2020
Sponsor
Prof. Daniele Zullino
1. Study Identification
Unique Protocol Identification Number
NCT03034408
Brief Title
Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects
Official Title
Effects of Nalmefene and Baclofen on Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects: A Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (undefined)
Primary Completion Date
December 17, 2018 (Actual)
Study Completion Date
December 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Daniele Zullino
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Impulsivity, Nalmefene, Baclofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol Use Disorder
Arm Type
Other
Arm Description
30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Arm Title
Healthy Control
Arm Type
Other
Arm Description
30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Nalmefene
Other Intervention Name(s)
Selincro
Intervention Type
Drug
Intervention Name(s)
Baclofen
Other Intervention Name(s)
Lioresal
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Other Intervention Name(s)
Mannitol
Primary Outcome Measure Information:
Title
Change in "Stop-signal reaction time" in the Stop-Signal Task
Description
Before-drug/after-drug difference of the stop-signal reaction time in the Stop Signal Task at Visit 2, Visit 3 and Visit 4.
Time Frame
0 and 2 hours post-dose
Secondary Outcome Measure Information:
Title
Change in "Equivalence point" in the Delay-Discounting Task
Description
Before-drug/after-drug difference of the Equivalence point" in the Delay-Discounting Task at Visit 2, Visit 3 and Visit 4.
Time Frame
0 and 2 hours post-dose
Title
Change in "Average number of pumps" delivered in the Balloon Analogue Risk Task
Description
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.
Time Frame
0 and 2 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele F Zullino, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Addictologie, Hôpitaux Universitaires de Genève
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.hug-ge.ch/addictologie/recherche
Description
website related to the study
Learn more about this trial
Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects
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