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

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ClinicalTrials.gov Identifier: NCT02195817
Recruitment Status : Terminated (The study was terminated due to enrolment challenges)
First Posted : July 21, 2014
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE July 21, 2014
Last Update Posted Date February 28, 2017
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
Change in the number of Heavy Drinking Days (HDDs) (days/month) [ Time Frame: Baseline to Month 3 ]
Cohort A
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
  • Change in Total Alcohol Consumption (TAC) (g/day) [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • 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 [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • RLDRL response; defined as a downward shift in DRL to low DRL or below [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • Response defined as ≥70% reduction in TAC [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • Response defined as 0 to 4 HDDs (days/month) [ Time Frame: Month 3 ]
    Cohort A
  • Change in Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: Baseline to Week 12 ]
    Cohort A
  • Clinical Global Impression - Global Improvement (CGI-I) [ Time Frame: Week 12 ]
    Cohort A
  • y-glutamyl transferase (y-GT) [ Time Frame: Week 12 ]
    Cohort A
  • Alanine aminotransferase (ALT) [ Time Frame: Week 12 ]
    Cohort A
  • Aspartate aminotransferase (AST) [ Time Frame: Week 12 ]
    Cohort A
  • Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom) [ Time Frame: Baseline to Week 12 ]
    Cohort A
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
  • Change in Total Alcohol Consumption (TAC) (g/day) [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • 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 [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • RLDRL response; defined as a downward shift in DRL to low DRL or below [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • Response defined as ≥70% reduction in TAC [ Time Frame: Baseline to Month 3 ]
    Cohort A
  • Response defined as 0 to 4 HDDs (days/month) [ Time Frame: Month 3 ]
    Cohort A
  • Change in Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: Baseline to Week 12 ]
    Cohort A
  • Clinical Global Impression - Global Improvement (CGI-I) [ Time Frame: Week 12 ]
    Cohort A
  • y-glutamyl transferase (y-GT) [ Time Frame: Week 12 ]
    Cohort A
  • Alanine aminotransferase (ALT) [ Time Frame: Week 12 ]
    Cohort A
  • Aspartate aminotransferase (AST) [ Time Frame: Week 12 ]
    Cohort A
  • Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom) [ Time Frame: Baseline to Week 12 ]
    Cohort A
  • Change in Alcohol Quality of Life Scale (AQoLS) (only for patients in France and the United Kingdom) [ Time Frame: Baseline to Week 12 ]
    Cohort A
  • Change in the number of HDDs (days/month) [ Time Frame: Baseline to Month 3 ]
    Cohort B
  • Change in TAC (g/day) [ Time Frame: Baseline to Month 3 ]
    Cohort B
  • Adverse events [ Time Frame: Up to Week 12 ]
    Cohorts A and B
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
Official Title  ICMJE Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
Brief 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A
    Other Name: nalmefene
  • Other: Initial psychosocial support: Cohort B
Study Arms  ICMJE
  • Selincro® 18 mg with continuous psychosocial support: Cohort A
    Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
    Intervention: Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A
  • Initial psychosocial support: Cohort B
    Initial psychosocial support followed by usual care practice, 12-week Observational Period
    Intervention: Other: Initial psychosocial support: Cohort B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 16, 2016)
378
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2014)
635
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

To ensure the study is broadly representative of primary care clinical practice, minimal inclusion and exclusion criteria are imposed with the main exclusion criteria relating to contraindications to the prescription of Selincro® and reflecting the indication wording in the SmPC.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02195817
Other Study ID Numbers  ICMJE 15892A
2013-004688-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP