Phase 3
N=718
Efficacy of Nalmefene in Patients With Alcohol Dependence
Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00812461 ↗Enrolled (actual)
718
Serious AEs
3.1%
Results posted
Jul 2013
Primary outcome: Primary: Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) — -10.58; -12.30 days — p=0.012
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
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) |
-10.58; -12.30 | 0.012 sig |
| PRIMARY Change From Baseline in the Monthly Total Alcohol Consumption (TAC) |
-54.06; -59.01 | 0.088 |
| SECONDARY Drinking Risk Level (RSDRL) Response |
47.9; 45.6 | 0.630 |
| SECONDARY Change From Baseline in Clinical Status Using CGI-S |
-1.04; -1.27 | 0.029 sig |
| SECONDARY Change in Clinical Status Using the CGI-I |
2.68; 2.51 | 0.111 |
| SECONDARY Liver Function Test Gamma-glutamyl Transferase (GGT) |
44.9; 43.3 | 0.529 |
| SECONDARY Liver Function Test Alanine Aminotransferase (ALAT) |
27.2; 25.0 | 0.049 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 (NCT00812461). 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.