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
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
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
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
NCT ID
NCT02752503
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
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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