Nalmefene in Alcohol Dependence and Borderline Personality Disorder

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02752503

Enrollment

Registered

2016-04-27

Start date

2015-03-31

Completion date

Unknown

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Borderline Personality Disorder

Brief summary

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

Interventions

DRUGNalmefene

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Spain

Contacts

Primary ContactJuan C Pascual, MD PhD

jpascual@santpau.cat0034 93 553 78 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026