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Completed

NCT Number: NCT00811941

Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CZ007, Litoměřice, Czechia

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About this study

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in patients with alcohol dependence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In- and outpatients who:

  • had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
  • had had ≥6 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

Exclusion criteria

The patient:

  • had a severe psychiatric disorder or an antisocial personality disorder
  • had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
  • had a history of delirium tremens or alcohol withdrawal seizures
  • reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
  • was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Placebo

Drug

as-needed use, tablets, orally, 52 weeks

Nalmefene

Drug

18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Other names: Selincro™

Primary outcomes

  1. Number of Patients With Adverse Events (AEs)

    Time frame: Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.

    Overview of AEs

  2. Percentage of Patients Who Withdrew Due to Intolerance to Treatment

    Time frame: Baseline to Week 52

  3. Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)

    Time frame: Baseline and Month 6

    Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.

  4. Change From Baseline in the Monthly Total Alcohol Consumption (TAC)

    Time frame: Baseline and Month 6

    TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).

Secondary outcomes

  1. Drinking Risk Level (RSDRL) Response

    Time frame: Month 6

    RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.

  2. Change From Baseline in Clinical Status Using CGI-S

    Time frame: Baseline and Week 24

    The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).

  3. Change in Clinical Status Using the CGI-I

    Time frame: Week 24

    The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).

  4. Liver Function Test Gamma-glutamyl Transferase (GGT)

    Time frame: Week 24

    GGT values

  5. Liver Function Test Alanine Aminotransferase (ALAT)

    Time frame: Week 24

    ALAT values

  6. Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)

    Time frame: Baseline and Month 13

    Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women.

  7. Change From Baseline in the Monthly Total Alcohol Consumption (TAC)

    Time frame: Baseline and Month 13

    TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).

  8. Drinking Risk Level (RSDRL) Response

    Time frame: Month 13

    RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.

  9. Change From Baseline in Clinical Status Using CGI-S

    Time frame: Baseline and Week 52

    The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).

  10. Change in Clinical Status Using the CGI-I

    Time frame: Week 52

    The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).

  11. Liver Function Test Gamma-glutamyl Transferase (GGT)

    Time frame: Week 52

    GGT values

  12. Liver Function Test Alanine Aminotransferase (ALAT)

    Time frame: Week 52

    ALAT values

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Safety, Tolerability and Efficacy Study of Nalmefene, as Needed Use, in Patients With Alcohol Dependence

Acronym: SENSE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2008
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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