Nalmefene in Alcohol Dependence and Borderline Personality Disorder

Not Applicable

• Conditions: Borderline Personality Disorder; Alcohol Use Disorder
• Interventions: Drug: Nalmefene

• Registration Number: NCT02752503
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Status Verified: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-22
• Last Update Submitted: 2016-04-22
• Study First Posted: 2016-04-27
• Last Update Posted: 2016-04-27
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nalmafene	Nalmefene	-

Primary Outcome Measures

Name	Time	Method
Days of excessive alcohol intake	2 months	Excessive alcohol intake: \>60 g in males; \>40 g in females
Daily average intake (grams)	2 months	Daily average intake (grams)

Secondary Outcome Measures

Name	Time	Method
Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)	2 months
Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)	2 months

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain