Alcohol Use DisorderNCT02752503
Nalmefene in Alcohol Dependence and Borderline Personality Disorder
A study testing Nalmefene in people with Alcohol Use Disorder and Borderline Personality Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Alcohol Use Disorder, Borderline Personality Disorder
- What is being tested?
- Nalmefene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Alcohol use disorder according to DSM 5
- Borderline personality disorder according to DSM 5
- CGI-BPD > 3
- Female have to use contraception
Who cannot join
- Other axis I disorders
- Severe organic disorder
- Pregnancy or breastfeeding
- Allergy to Nalmefene
- Subjects with Opioids use disorder or in treatment with opioid agonists
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Juan C Pascual, Md PhD, 0034 93 553 78 40, jpascual@santpau.cat
About this study
Official title: Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder
The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.
- Being tested
- Nalmefene
- Medical subject headings
- Alcoholism, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalmefeneDrug
| Study group | Role | What they receive |
|---|---|---|
| Nalmafene | Experimental | Not described Receives: Drug: Nalmefene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of excessive alcohol intake
Excessive alcohol intake: >60 g in males; >40 g in females
Measured: 2 months
Daily average intake (grams)
Daily average intake (grams)
Measured: 2 months
Secondary outcomes (2)
Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)
Measured: 2 months
Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari General de Catalunya
- Responsible party
- Sponsor
- Investigators
- Juan C Pascual, MD PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752503
- Sponsor's protocol ID
- IIBSP-NAL-2014-76
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT02752503
- Acronym / sponsor ID
- IIBSP-NAL-2014-76
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Hospital Universitari General de Catalunya
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nalmafene | Experimental | Drug: Nalmefene |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Alcohol use disorder according to DSM 5
- Borderline personality disorder according to DSM 5
- CGI-BPD > 3
- Female have to use contraception
Key exclusion criteria (5 listed)
- Other axis I disorders
- Severe organic disorder
- Pregnancy or breastfeeding
- Allergy to Nalmefene
- Subjects with Opioids use disorder or in treatment with opioid agonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalmefene | Drug | Nalmafene |
Primary outcome
Days of excessive alcohol intake
Time frame: 2 months
Excessive alcohol intake: >60 g in males; >40 g in females
Daily average intake (grams)
Time frame: 2 months
Daily average intake (grams)
2 secondary outcomes
Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)
Time frame: 2 months
Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Pascual, MD PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nalmefene in people with Alcohol Use Disorder and Borderline Personality Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan C Pascual, MD PhD (0034 93 553 78 40, jpascual@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of excessive alcohol intake (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.