Nalmefene in Alcohol Dependence and Borderline Personality Disorder

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alcohol Use Disorder Borderline Personality Disorder

Interventions

NalmefeneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Days of excessive alcohol intake

Excessive alcohol intake: \>60 g in males; \>40 g in females

Time frame: 2 months

Daily average intake (grams)

Time frame: 2 months

Secondary Outcomes

Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)

Time frame: 2 months

Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)

Time frame: 2 months

Central Contacts

Juan C Pascual, MD PhD

CONTACT

0034 93 553 78 40 jpascual@santpau.cat

Data from ClinicalTrials.gov

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