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
NCT ID: NCT01969617
Last Updated: 2014-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Nalmefene 18 mg, then placebo
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Nalmefene 18 mg, then placebo
One single oral dose Nalmefene on Day 1 and Placebo on Day 8
Placebo, then Nalmefene 18 mg
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Placebo, then Nalmefene 18 mg
One single oral dose Placebo on Day 1 and Nalmefene on Day 8
Interventions
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Nalmefene 18 mg, then placebo
One single oral dose Nalmefene on Day 1 and Placebo on Day 8
Placebo, then Nalmefene 18 mg
One single oral dose Placebo on Day 1 and Nalmefene on Day 8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
65 Years
MALE
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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GB801
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2013-001154-98
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15660A
Identifier Type: -
Identifier Source: org_study_id