Phase 3
N=604
Efficacy of Nalmefene in Patients With Alcohol Dependence
Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00811720 ↗Enrolled (actual)
604
Serious AEs
5.9%
Results posted
Jul 2013
Primary outcome: Primary: Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) — -8.91; -11.24 days — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Nalmefene (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lundbeck A/S
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) |
-8.91; -11.24 | 0.002 sig |
| PRIMARY Change From Baseline in the Monthly Total Alcohol Consumption (TAC) |
-39.70; -50.66 | <0.001 sig |
| SECONDARY Drinking Risk Level (RSDRL) Response |
44.3; 36.9 | 0.039 sig |
| SECONDARY Change From Baseline in Clinical Status Using CGI-S |
-0.90; -1.27 | <0.001 sig |
| SECONDARY Change in Clinical Status Using the CGI-I |
2.65; 2.30 | <0.001 sig |
| SECONDARY Liver Function Test Gamma-glutamyl Transferase (GGT) |
45.7; 40.3 | 0.009 sig |
| SECONDARY Liver Function Test Alanine Aminotransferase (ALAT) |
28.1; 25.4 | 0.011 sig |
Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
Eligibility Criteria
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 HDDs in the 4 weeks preceding the Screening Visit
- had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit
Exclusion Criteria
The patient:
- had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
- had 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
- reported current or recent treatment with antipsychotics or antidepressants
- was pregnant or breast-feeding
Other protocol-defined inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00811720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.