A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-09

Study Completion Date

2016-07-30

Brief Summary

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The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.

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Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nalmefene hydrochloride 10 mg

Group Type EXPERIMENTAL

Nalmefene hydrochloride

Intervention Type DRUG

As-needed; tablets, orally

Nalmefene hydrochloride 20 mg

Group Type EXPERIMENTAL

Nalmefene hydrochloride

Intervention Type DRUG

As-needed; tablets, orally

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

As-needed; tablets, orally

Interventions

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Nalmefene hydrochloride

As-needed; tablets, orally

Intervention Type DRUG

Placebo

As-needed; tablets, orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese males and females aged 20 or above who have signed the informed consent form
* The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and confirmed by Mini-international Neuropsychiatric Interview (M. I. N. I.)
* The patient has a drinking risk level of High or above (\> 60 g for men and \> 40 g for women) both at the Screening Visit and at the Randomization Visit .

Exclusion Criteria

* The patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to DSM-IV-TR and confirmed by M. I. N. I.
* The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No