Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Sponsor
Prof. Daniele Zullino (Other)
Overall Status
Completed
CT.gov ID
NCT03034408
Collaborator
(none)
37
1
2
29.5
1.3

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Dec 17, 2018
Actual Study Completion Date :
Dec 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Alcohol Use Disorder

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: Nalmefene
Other Names:
  • Selincro
  • Drug: Baclofen
    Other Names:
  • Lioresal
  • Drug: Placebo Oral Capsule
    Other Names:
  • Mannitol
  • Other: Healthy Control

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

    Drug: Nalmefene
    Other Names:
  • Selincro
  • Drug: Baclofen
    Other Names:
  • Lioresal
  • Drug: Placebo Oral Capsule
    Other Names:
  • Mannitol
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Addictologie, Hôpitaux Universitaires de Genève Geneva Switzerland 1202

    Sponsors and Collaborators

    • Prof. Daniele Zullino

    Investigators

    • Principal Investigator: Daniele F Zullino, MD, University Hospital, Geneva

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Prof. Daniele Zullino, Prof., University Hospital, Geneva
    ClinicalTrials.gov Identifier:
    NCT03034408
    Other Study ID Numbers:
    • 2015-00160
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Oct 29, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Prof. Daniele Zullino, Prof., University Hospital, Geneva
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 29, 2020