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

October 28, 2020 updated by: Prof. Daniele Zullino

Effects of Nalmefene and Baclofen on Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects: A Randomized, Placebo-controlled Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1202
        • Service d'Addictologie, Hôpitaux Universitaires de Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Placebo Oral Capsule
Other Names:
  • Mannitol
Drug: Nalmefene
Other Names:
  • Selincro
Drug: Baclofen
Other Names:
  • Lioresal
Other: Healthy Control
30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Drug: Placebo Oral Capsule
Other Names:
  • Mannitol
Drug: Nalmefene
Other Names:
  • Selincro
Drug: Baclofen
Other Names:
  • Lioresal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in "Stop-signal reaction time" in the Stop-Signal Task
Time Frame: 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.
0 and 2 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in "Equivalence point" in the Delay-Discounting Task
Time Frame: 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.
0 and 2 hours post-dose
Change in "Average number of pumps" delivered in the Balloon Analogue Risk Task
Time Frame: 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.
0 and 2 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Daniele Zullino

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 17, 2018

Study Completion (Actual)

December 17, 2018

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-00160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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