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Alcohol DependencePhase 4NCT02195817

Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

A Phase 4 study testing Selincro® 18 mg with continuous psychosocial support: Cohort A and Initial psychosocial support: Cohort B in people with Alcohol Dependence, run by H. Lundbeck A/S at 48 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Dependence
What is being tested?
Selincro® 18 mg with continuous psychosocial support: Cohort A and Initial psychosocial support: Cohort B
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
48 sitesin 4 countries
Study dates
Aug 2014to Feb 2016
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has alcohol dependence diagnosed according to ICD-10.
  • The patient has had a high DRL in the 4 weeks preceding the Screening Visit.
  • The patient is a man or woman, aged ≥18 years.
  • The patient provides a stable address and telephone number.

Who cannot join

  • The patient has one or more contraindications to the prescription of Selincro®:
  • hypersensitivity to the active substance or to any of the excipients
  • taking opioid analgesics
  • current or recent opioid addiction
  • acute symptoms of opioid withdrawal
  • recent use of opioids suspected
Show all 12Show fewer
  • severe hepatic impairment (Child-Pugh classification)
  • severe renal impairment (eGFR <30 ml/min per 1.73 m2)
  • a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)
  • The patient has had <6 HDDs (defined by the European Medicines Agency as a day with an alcohol consumption >60g for men or >40g for women) in the 4 weeks preceding the Screening Visit.
  • The patient has physical alcohol withdrawal symptoms and requires immediate detoxification for which inpatient treatment is required.
  • The patient is currently participating or has recently (in the 4 weeks preceding the Screening Visit) participated in a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, detoxification treatment, and treatment of alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken nalmefene in the 6 months preceding the Screening Visit.

Trial locations and contacts

48 sites in 4 countries.

48 sites in 4 countries

Spain13 sites

  • ES001

    Badalona

  • ES010

    Badalona

  • ES003

    Barcelona

  • ES004

    Barcelona

  • ES008

    Canet de Mar

  • ES007

    el Prat de Llobregat

  • ES006

    Hospitalet Del Llobregat

  • ES009

    Hospitalet Del Llobregat

  • ES011

    Hospitalet Del Llobregat

  • ES013

    Matar

  • ES002

    Mataró

  • ES012

    Sabadell

  • ES005

    Tarragona

Other trials in Spain

France12 sites

  • FR010

    Bécon-les-Granits

  • FR001

    Bordeaux

  • FR005

    Bordeaux

  • FR009

    Cestas

  • FR012

    Chauny

  • FR002

    Coulounieix-Chamiers

  • FR008

    La Teste-de-Buch

  • FR007

    Mont-de-Marsan

  • FR011

    Narbonne

  • FR003

    Targon

  • FR006

    Tonneins

  • FR004

    Vieux-Boucau-les-Bains

Other trials in France

United Kingdom12 sites

  • GB011

    Ballymena

  • GB008

    Belfast

  • GB009

    Belfast

  • GB004

    Cardiff

  • GB005

    Cardiff

  • GB001

    Coatbridge

  • GB002

    Glasgow

  • GB003

    Lanarkshire

  • GB006

    Swansea

  • GB007

    Swansea

  • GB010

    Swansea

  • GB106

    Swansea

Other trials in United Kingdom

Germany11 sites

  • DE002

    Berlin

  • DE005

    Berlin

  • DE006

    Essen

  • DE003

    Jahnsdorf

  • DE004

    Jahnsdorf

  • DE011

    Mannheim

  • DE009

    Nuremberg

  • DE010

    Offenbach

  • DE001

    Wallerfing

  • DE007

    Weilburg

  • DE008

    Weinheim

Other trials in Germany

About this study

Official title: Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care

Read the detailed description

635 patients are planned (total number of patients) with 475 patients treated with Selincro® (Cohort A) and 160 patients not treated with Selincro® (Cohort B) to determine the reduction in alcohol consumption in patients with alcohol dependence.

Cohort A will comprise patients who maintain a high drinking risk level (DRL, defined by World Health Organization (WHO) as >60g alcohol/day for a man or >40g alcohol/day for a woman), or above, in the period between the Screening and Inclusion Visits.

Cohort B will comprise patients who reduce their alcohol consumption in the period between the Screening and Inclusion visits, that is, patients who do not maintain at least a high DRL at the Inclusion Visit (and are therefore not eligible for treatment with nalmefene according to the SmPC).

Being tested
Selincro® 18 mg with continuous psychosocial support: Cohort A, Initial psychosocial support: Cohort B
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selincro® 18 mg with continuous psychosocial support: Cohort ADrug

    Also called nalmefene

  • Initial psychosocial support: Cohort BOther

Study groups in NCT02195817
Study groupRoleWhat they receive
Selincro® 18 mg with continuous psychosocial support: Cohort AOtherSelincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
Receives: Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A
Initial psychosocial support: Cohort BOtherInitial psychosocial support followed by usual care practice, 12-week Observational Period
Receives: Other: Initial psychosocial support: Cohort B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of Heavy Drinking Days (HDDs) (days/month)

    Cohort A

    Measured: Baseline to Month 3

Secondary outcomes (11)

  1. Change in Total Alcohol Consumption (TAC) (g/day)

    Cohort A

    Measured: Baseline to Month 3

  2. Drinking Risk Level response (RSDRL); defined as a downward shift in Drinking Risk Level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or below; for patients with a high DRL at baseline, a shift to low DRL or below

    Cohort A

    Measured: Baseline to Month 3

  3. RLDRL response; defined as a downward shift in DRL to low DRL or below

    Cohort A

    Measured: Baseline to Month 3

  4. Response defined as ≥70% reduction in TAC

    Cohort A

    Measured: Baseline to Month 3

  5. Response defined as 0 to 4 HDDs (days/month)

    Cohort A

    Measured: Month 3

  6. Change in Clinical Global Impression - Severity of Illness (CGI-S) score

    Cohort A

    Measured: Baseline to Week 12

  7. Clinical Global Impression - Global Improvement (CGI-I)

    Cohort A

    Measured: Week 12

  8. y-glutamyl transferase (y-GT)

    Cohort A

    Measured: Week 12

  9. Alanine aminotransferase (ALT)

    Cohort A

    Measured: Week 12

  10. Aspartate aminotransferase (AST)

    Cohort A

    Measured: Week 12

  11. Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)

    Cohort A

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Why it stopped: The study was terminated due to enrolment challenges

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195817
Sponsor's protocol ID
15892A
Other IDs
2013-004688-30
Status last verified
Feb 2017
First submitted
17 Jul 2014
Last updated
28 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Selincro® 18 mg with continuous psychosocial support: Cohort A and Initial psychosocial support: Cohort B in people with Alcohol Dependence, run by H. Lundbeck A/S at 48 sites in 4 countries.

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 12 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: stopped early, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Spain, France, United Kingdom, Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to enrolment challenges). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the number of Heavy Drinking Days (HDDs) (days/month) (time frame: Baseline to Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195817.

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 28 Feb 2017.

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