Effects of Nalmefene After Single Dose on the Blood Oxyge... | NCT01969617

Studies
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

Sponsor

H. Lundbeck A/S

Status

Completed

Last Update Posted

Nov 11, 2014Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Alcohol Dependence

Interventions

Nalmefene 18 mg, then placebo
Placebo, then Nalmefene 18 mg

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2013-001154-98	EudraCT Number

Official Title

Interventional, Randomized, Double-blind, Cross-over, Placebo-controlled Study to Investigate the Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (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

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Not provided

First Submitted Date

Oct 17, 2013

First Submission Date that Met QC Criteria

Oct 21, 2013

First Posted Date

Oct 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2014

Last Update Posted Date

Nov 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nalmefene 18 mg, then placebo	Drug	One single oral dose Nalmefene on Day 1 and Placebo on Day 8	Nalmefene 18 mg, then placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Safety	Number of adverse events	Up to Day 8 and a 10-day safety follow up
Risk of suicidality	Columbia-Suicide Severity Rating Scale (CSSRS) score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@lundbeck.com	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GB801		London		NW10 7EW	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28216062	Derived	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.

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders