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

NCT01969617 | Completed Phase 1

• 2 other identifiers: 15660A2013-001154-98
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task

  Day 1

Secondary Outcomes (2)

• Safety

  Up to Day 8 and a 10-day safety follow up

• Risk of suicidality

  Up to Day 8

Study Arms (2)

Nalmefene 18 mg, then placebo

EXPERIMENTAL

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Drug: Nalmefene 18 mg, then placebo

Placebo, then Nalmefene 18 mg

PLACEBO COMPARATOR

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Drug: Placebo, then Nalmefene 18 mg

Interventions

Nalmefene 18 mg, then placebo DRUG

One single oral dose Nalmefene on Day 1 and Placebo on Day 8

Also known as: Selincro®

Nalmefene 18 mg, then placebo

Placebo, then Nalmefene 18 mg DRUG

One single oral dose Placebo on Day 1 and Nalmefene on Day 8

Also known as: Selincro®

Placebo, then Nalmefene 18 mg

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

GB801

London, NW10 7EW, United Kingdom

Location

Related Publications (1)

• Quelch DR, Mick I, McGonigle J, Ramos AC, Flechais RSA, Bolstridge M, Rabiner E, Wall MB, Newbould RD, Steiniger-Brach B, van den Berg F, Boyce M, Ostergaard Nilausen D, Breuning Sluth L, Meulien D, von der Goltz C, Nutt D, Lingford-Hughes A. Nalmefene Reduces Reward Anticipation in Alcohol Dependence: An Experimental Functional Magnetic Resonance Imaging Study. Biol Psychiatry. 2017 Jun 1;81(11):941-948. doi: 10.1016/j.biopsych.2016.12.029. Epub 2017 Jan 10.

  PMID: 28216062 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 25, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

GB (1)