NCT00811720

Brief Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
598

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2008

Geographic Reach
4 countries

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

July 9, 2013

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

December 18, 2008

Results QC Date

March 12, 2013

Last Update Submit

July 5, 2013

Conditions

Alcohol Dependence

Keywords

Alcohol-Related DisordersAlcoholismMental DisordersCentral Nervous System Agents

Outcome Measures

Primary Outcomes (2)

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

    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.

    Baseline and Month 6

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

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

    Baseline and Month 6

Secondary Outcomes (5)

  • Drinking Risk Level (RSDRL) Response

    Month 6

  • Change From Baseline in Clinical Status Using CGI-S

    Baseline and Week 24

  • Change in Clinical Status Using the CGI-I

    Week 24

  • Liver Function Test Gamma-glutamyl Transferase (GGT)

    Week 24

  • Liver Function Test Alanine Aminotransferase (ALAT)

    Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Nalmefene

EXPERIMENTAL
Drug: Nalmefene

Interventions

PlaceboDRUG

as-needed use, tablets, orally, 6 months

Placebo
NalmefeneDRUG

18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Also known as: Selincro™
Nalmefene

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

AT001

Linz, 4020, Austria

Location

AT004

Salzburg, 5020, Austria

Location

AT003

Vienna, 1090, Austria

Location

AT002

Vienna, 1230, Austria

Location

FI008

Helsinki, 560, Finland

Location

FI009

Helsinki, 800, Finland

Location

FI007

Jarvenpaa, 4480, Finland

Location

FI013

Kuopio, 70100, Finland

Location

FI004

Kuusankoski, 45700, Finland

Location

FI001

Mikkeli, 50100, Finland

Location

FI015

Oulu, 90100, Finland

Location

FI003

Tampere, 33100, Finland

Location

FI002

Tampere, 339000, Finland

Location

FI014

Turku, 20100, Finland

Location

FI011

Vantaa, 1600, Finland

Location

DE011

Bad Saarow, 15526, Germany

Location

DE016

Berlin, 10245, Germany

Location

DE005

Berlin, 10365, Germany

Location

DE002

Berlin, 10629, Germany

Location

DE017

Berlin, 12524, Germany

Location

DE008

Berlin, 13156, Germany

Location

DE019

Berlin, 13187, Germany

Location

DE003

Essen, NW 45136, Germany

Location

DE006

Hamburg, 20246, Germany

Location

DE001

Hamburg, 22143, Germany

Location

DE007

Leukersdorf, 09387, Germany

Location

DE003

Mannheim, BW68159, Germany

Location

DE014

Munich, 80336, Germany

Location

DE010

Regensburg, BY 93053, Germany

Location

DE018

Siegen, 57072, Germany

Location

DE020

Wallerfing, 94574, Germany

Location

SE011

Gothenburg, 402 76, Sweden

Location

SE005

Kalmar, 391 85, Sweden

Location

SE006

Linköping, 857 58, Sweden

Location

SE001

Malmo, 211 22, Sweden

Location

SE004

Stockholm, 118 91, Sweden

Location

SE002

Stockholm, 141 86, Sweden

Location

SE008

Stockholm, 17176, Sweden

Location

SE009

Uppsala, 756 43, Sweden

Location

Related Publications (4)

  • Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013 Apr 15;73(8):706-13. doi: 10.1016/j.biopsych.2012.10.020. Epub 2012 Dec 11.

    PMID: 23237314RESULT

  • Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.

    PMID: 25832297DERIVED

  • Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

    PMID: 25227627DERIVED

  • van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19.

    PMID: 23873853DERIVED

MeSH Terms

Conditions

AlcoholismAlcohol-Related DisordersMental Disorders

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced Disorders

Results Point of Contact

Title
H. Lundbeck A/S
Organization
H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
+45 3630 1311

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 19, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

July 9, 2013

Results First Posted

July 9, 2013

Record last verified: 2013-07

Locations

FI(11)AU(4)SE(8)DE(16)