Nalmefene in Alcohol Dependence and Borderline Personality Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02752503
• Other study ID #: IIBSP-NAL-2014-76
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 22, 2016
• Start date: March 2015

Study information

• Verified date: April 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Juan C Pascual, MD PhD
• Phone: 0034 93 553 78 40
• Email: jpascual[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Borderline Personality Disorder
• Disease
• Personality Disorders

Intervention

Drug:
• Nalmefene

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Hospital General de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of excessive alcohol intake	Excessive alcohol intake: >60 g in males; >40 g in females	2 months	No
Primary	Daily average intake (grams)	Daily average intake (grams)	2 months	No
Secondary	Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)		2 months	No
Secondary	Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)		2 months	No