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Nalmefene in Alcohol Dependence and Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT02752503
Recruitment Status : Unknown
Verified April 2016 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
Hospital Universitari General de Catalunya
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Borderline Personality Disorder Drug: Nalmefene Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder
Study Start Date : March 2015
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nalmafene Drug: Nalmefene



Primary Outcome Measures :
  1. Days of excessive alcohol intake [ Time Frame: 2 months ]
    Excessive alcohol intake: >60 g in males; >40 g in females

  2. Daily average intake (grams) [ Time Frame: 2 months ]
    Daily average intake (grams)


Secondary Outcome Measures :
  1. Borderline symptoms on the Borderline Symptom List - 23 (BSL-23) [ Time Frame: 2 months ]
  2. Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD) [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752503


Contacts
Contact: Juan C Pascual, MD PhD 0034 93 553 78 40 jpascual@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Juan C Pascual, Md PhD    0034 93 553 78 40    jpascual@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02752503     History of Changes
Other Study ID Numbers: IIBSP-NAL-2014-76
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Disease
Alcohol Drinking
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Drinking Behavior
Mental Disorders
Nalmefene
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents