Nalmefene in Alcohol Dependence and Borderline Personality Disorder

NCT ID: NCT02752503

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.

Detailed Description

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Conditions

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Alcohol Use Disorder Borderline Personality Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nalmafene

Group Type EXPERIMENTAL

Nalmefene

Intervention Type DRUG

Interventions

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Nalmefene

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Alcohol use disorder according to DSM 5
* Borderline personality disorder according to DSM 5
* CGI-BPD \> 3
* Female have to use contraception

Exclusion Criteria

* Other axis I disorders
* Severe organic disorder
* Pregnancy or breastfeeding
* Allergy to Nalmefene
* Subjects with Opioids use disorder or in treatment with opioid agonists
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari General de Catalunya

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan C Pascual, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan C Pascual, MD PhD

Role: CONTACT

0034 93 553 78 40

Facility Contacts

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Juan C Pascual, Md PhD

Role: primary

0034 93 553 78 40

Other Identifiers

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IIBSP-NAL-2014-76

Identifier Type: -

Identifier Source: org_study_id

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