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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

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

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A Other: Initial psychosocial support: Cohort B Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
Actual Study Start Date : August 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Selincro® 18 mg with continuous psychosocial support: Cohort A
Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
Drug: Selincro® 18 mg with continuous psychosocial support: Cohort A
Other Name: nalmefene

Initial psychosocial support: Cohort B
Initial psychosocial support followed by usual care practice, 12-week Observational Period
Other: Initial psychosocial support: Cohort B



Primary Outcome Measures :
  1. Change in the number of Heavy Drinking Days (HDDs) (days/month) [ Time Frame: Baseline to Month 3 ]
    Cohort A


Secondary Outcome Measures :
  1. Change in Total Alcohol Consumption (TAC) (g/day) [ Time Frame: Baseline to Month 3 ]
    Cohort A

  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 [ Time Frame: Baseline to Month 3 ]
    Cohort A

  3. RLDRL response; defined as a downward shift in DRL to low DRL or below [ Time Frame: Baseline to Month 3 ]
    Cohort A

  4. Response defined as ≥70% reduction in TAC [ Time Frame: Baseline to Month 3 ]
    Cohort A

  5. Response defined as 0 to 4 HDDs (days/month) [ Time Frame: Month 3 ]
    Cohort A

  6. Change in Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: Baseline to Week 12 ]
    Cohort A

  7. Clinical Global Impression - Global Improvement (CGI-I) [ Time Frame: Week 12 ]
    Cohort A

  8. y-glutamyl transferase (y-GT) [ Time Frame: Week 12 ]
    Cohort A

  9. Alanine aminotransferase (ALT) [ Time Frame: Week 12 ]
    Cohort A

  10. Aspartate aminotransferase (AST) [ Time Frame: Week 12 ]
    Cohort A

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195817


  Show 48 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Additional Information:
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02195817     History of Changes
Other Study ID Numbers: 15892A
2013-004688-30 ( EudraCT Number )
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents