Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Alcohol Dependence

Treatments: Drug: Placebo, then Nalmefene 18 mg; Drug: Nalmefene 18 mg, then placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01969617

2013-001154-98 (EudraCT Number)

15660A

Details and patient eligibility

About

To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene

Enrollment: 22 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject has alcohol dependence, diagnosed according to DSM-IV-TR™.

Exclusion criteria

• The subject is seeking treatment for alcohol dependence.
• The subject has had <6 heavy drinking days (HDDs) in the 4 weeks prior to the Screening Visit.
• The subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) <4 weeks prior to the Screening Visit.
• The subject has >5 consecutive abstinence days in the 4 weeks prior to the Screening Visit.
• The subject has a Revised Clinical Institute Withdrawal Assessment of Alcohol Scale, (CIWA-Ar), score ≥10.
• The subject is, in the opinion of the investigator, at significant risk of suicide or meets the exclusion criteria based on C-SSRS.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Nalmefene 18 mg, then placebo

Experimental group

Description:

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Treatment:

Drug: Nalmefene 18 mg, then placebo

Placebo, then Nalmefene 18 mg

Placebo Comparator group

Description:

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Treatment:

Drug: Placebo, then Nalmefene 18 mg