Nalmefene in Alcohol Dependence and Borderline Personality Disorder

April 22, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nalmafene
Drug: Nalmefene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of excessive alcohol intake
Time Frame: 2 months
Excessive alcohol intake: >60 g in males; >40 g in females
2 months
Daily average intake (grams)
Time Frame: 2 months
Daily average intake (grams)
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)
Time Frame: 2 months
2 months
Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Hospital Universitari General de Catalunya

Investigators

  • Principal Investigator: Juan C Pascual, MD PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-NAL-2014-76

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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