NCT03034408

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2.5 years

First QC Date

November 3, 2016

Last Update Submit

October 28, 2020

Conditions

Alcohol Use Disorder

Keywords

ImpulsivityNalmefeneBaclofen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in "Equivalence point" in the Delay-Discounting Task

    0 and 2 hours post-dose

  • Change in "Average number of pumps" delivered in the Balloon Analogue Risk Task

    0 and 2 hours post-dose

Study Arms (2)

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

Drug: NalmefeneDrug: BaclofenDrug: Placebo Oral Capsule

Healthy Control

OTHER

30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule

Drug: NalmefeneDrug: BaclofenDrug: Placebo Oral Capsule

Interventions

NalmefeneDRUG
Also known as: Selincro
Alcohol Use DisorderHealthy Control
BaclofenDRUG
Also known as: Lioresal
Alcohol Use DisorderHealthy Control
Placebo Oral CapsuleDRUG
Also known as: Mannitol
Alcohol Use DisorderHealthy Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20),
  • sex and age-matched healthy controls,
  • over 18, informed consent.

You may not qualify if:

  • opiate-treatment,
  • contra-indications for Nalmefene and/or Baclofen,
  • unstable psychiatric disorder,
  • pregnancy,
  • acute withdrawal syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Addictologie, Hôpitaux Universitaires de Genève

Geneva, 1202, Switzerland

Location

Related Links

MeSH Terms

Conditions

AlcoholismImpulsive Behavior

Interventions

nalmefeneBaclofenMannitol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSugar AlcoholsAlcoholsCarbohydrates

Study Officials

  • Daniele F Zullino, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 3, 2016

First Posted

January 27, 2017

Study Start

July 1, 2016

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)