Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034408
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Daniele Zullino, University Hospital, Geneva

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
Alcohol Use Disorder Drug: Nalmefene Drug: Baclofen Drug: Placebo Oral Capsule Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
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 Name: Selincro

Drug: Baclofen
Other Name: Lioresal

Drug: Placebo Oral Capsule
Other Name: Mannitol

Healthy Control
30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
Drug: Nalmefene
Other Name: Selincro

Drug: Baclofen
Other Name: Lioresal

Drug: Placebo Oral Capsule
Other Name: Mannitol




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034408


Contacts
Layout table for location contacts
Contact: Daniele F Zullino, MD +41223725750 daniele.zullino@hcuge.ch

Locations
Layout table for location information
Switzerland
Service d'Addictologie, Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland, 1202
Contact: Zullino F Daniele, MD    +41223725750    daniele.zullino@hcuge.ch   
Sponsors and Collaborators
Prof. Daniele Zullino
Investigators
Layout table for investigator information
Principal Investigator: Daniele F Zullino, MD University Hospital, Geneva

Additional Information:
Layout table for additonal information
Responsible Party: Prof. Daniele Zullino, Prof., University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03034408     History of Changes
Other Study ID Numbers: 2015-00160
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Daniele Zullino, University Hospital, Geneva:
Impulsivity
Nalmefene
Baclofen

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Alcoholism
Alcohol Drinking
Impulsive Behavior
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Naltrexone
Nalmefene
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents