NCT02752503

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

April 19, 2016

Last Update Submit

April 22, 2016

Conditions

Alcohol Use DisorderBorderline Personality Disorder

Outcome Measures

Primary Outcomes (2)

  • Days of excessive alcohol intake

    Excessive alcohol intake: \>60 g in males; \>40 g in females

    2 months

  • Daily average intake (grams)

    Daily average intake (grams)

    2 months

Secondary Outcomes (2)

  • Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)

    2 months

  • Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)

    2 months

Study Arms (1)

Nalmafene

EXPERIMENTAL
Drug: Nalmefene

Interventions

NalmefeneDRUG
Nalmafene

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Alcohol use disorder according to DSM 5
  • Borderline personality disorder according to DSM 5
  • CGI-BPD \> 3
  • Female have to use contraception

You may not qualify if:

  • Other axis I disorders
  • Severe organic disorder
  • Pregnancy or breastfeeding
  • Allergy to Nalmefene
  • Subjects with Opioids use disorder or in treatment with opioid agonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

AlcoholismBorderline Personality Disorder

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPersonality Disorders

Study Officials

  • Juan C Pascual, MD PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan C Pascual, MD PhD

CONTACT

0034 93 553 78 40jpascual@santpau.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 27, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

ES(1)