Nalmefene in Alcohol Dependence and Borderline Personalit... | NCT02752503

Studies
Nalmefene in Alcohol Dependence and Borderline Personality Disorder

NCT02752503

Sponsor

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

Status

Unknown status

Last Update Posted

Apr 27, 2016Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Alcohol Use Disorder
Borderline Personality Disorder

Interventions

Nalmefene

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Apr 22, 2016

First Posted Date

Apr 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Name	Class
Hospital Universitari General de Catalunya	OTHER

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Nalmafene	Experimental		Drug: Nalmefene

Name	Type	Description	Arm Group Labels	Other Names
Nalmefene	Drug		Nalmafene

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juan C Pascual, MD PhD	Contact	0034 93 553 78 40		jpascual@santpau.cat

Overall Officials

Name	Affiliation	Role
Juan C Pascual, MD PhD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de la Santa Creu i Sant Pau	Recruiting	Barcelona	Barcelona	08025	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism
D001883	Borderline Personality Disorder

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C038981	nalmefene

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided