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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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Nalmefene 18 mg, then placebo
Placebo, then Nalmefene 18 mg
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • GB801

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nalmefene 18 mg, then placebo

Placebo, then Nalmefene 18 mg

Arm Description

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety
Number of adverse events
Risk of suicidality
Columbia-Suicide Severity Rating Scale (CSSRS) score

Full Information

First Posted
October 17, 2013
Last Updated
November 10, 2014
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01969617
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nalmefene 18 mg, then placebo
Arm Type
Experimental
Arm Description
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Arm Title
Placebo, then Nalmefene 18 mg
Arm Type
Placebo Comparator
Arm Description
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Intervention Type
Drug
Intervention Name(s)
Nalmefene 18 mg, then placebo
Other Intervention Name(s)
Selincro®
Intervention Description
One single oral dose Nalmefene on Day 1 and Placebo on Day 8
Intervention Type
Drug
Intervention Name(s)
Placebo, then Nalmefene 18 mg
Other Intervention Name(s)
Selincro®
Intervention Description
One single oral dose Placebo on Day 1 and Nalmefene on Day 8
Primary Outcome Measure Information:
Title
Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Safety
Description
Number of adverse events
Time Frame
Up to Day 8 and a 10-day safety follow up
Title
Risk of suicidality
Description
Columbia-Suicide Severity Rating Scale (CSSRS) score
Time Frame
Up to Day 8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
GB801
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28216062
Citation
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.
Results Reference
derived

Learn more about this trial

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

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