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Nalmefene in Alcohol Dependence and Borderline Personality Disorder

Primary Purpose

Alcohol Use Disorder, Borderline Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nalmefene
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de la Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nalmafene

Arm Description

Outcomes

Primary Outcome Measures

Days of excessive alcohol intake
Excessive alcohol intake: >60 g in males; >40 g in females
Daily average intake (grams)
Daily average intake (grams)

Secondary Outcome Measures

Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)
Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)

Full Information

First Posted
April 19, 2016
Last Updated
April 22, 2016
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Hospital Universitari General de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT02752503
Brief Title
Nalmefene in Alcohol Dependence and Borderline Personality Disorder
Official Title
Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Hospital Universitari General de Catalunya

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nalmafene
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nalmefene
Primary Outcome Measure Information:
Title
Days of excessive alcohol intake
Description
Excessive alcohol intake: >60 g in males; >40 g in females
Time Frame
2 months
Title
Daily average intake (grams)
Description
Daily average intake (grams)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)
Time Frame
2 months
Title
Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan C Pascual, MD PhD
Phone
0034 93 553 78 40
Email
jpascual@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Pascual, MD PhD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan C Pascual, Md PhD
Phone
0034 93 553 78 40
Email
jpascual@santpau.cat

12. IPD Sharing Statement

Learn more about this trial

Nalmefene in Alcohol Dependence and Borderline Personality Disorder

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