Nalmefene for Alcoholic Intoxication

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alcoholic Intoxication+1 More
Nalmefene - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests if the drug nalmefene, which interferes with opioid receptors, reduces drinking. It also tests how different forms of the gene OPRM1 affects nalmefene's efficacy.

Eligible Conditions
  • Alcoholic Intoxication
  • AUD

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alcoholic Intoxication

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Post-administration

Post-administration
Genotypic modulation (at the OPRM1 118 location) of Nalmafene's effects on measures (BOLD signal change during alcohol reward processing and IV alcohol self-administration).
Amygdaloid structure
Nalmefene-induced changes in IV alcohol self-administration
Post-adminstration
Nalmefene-induced BOLD signal changes in neural processing of aversive stimuli during fMRI

Trial Safety

Safety Progress

1 of 3

Other trials for Alcoholic Intoxication

Side Effects for

Nalmefene 18.06 mg
28%Dizziness
27%Nausea
18%Fatigue
12%Nasopharyngitis
12%Headache
11%Sleep disorder
10%Insomnia
8%Vomiting
5%Hyperhidrosis
1%Alcoholism
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00811720) in the Nalmefene 18.06 mg ARM group. Side effects include: Dizziness with 28%, Nausea with 27%, Fatigue with 18%, Nasopharyngitis with 12%, Headache with 12%.

Trial Design

2 Treatment Groups

Drug
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Nalmefene · Has Placebo Group · Phase 1

Drug
Drug
Experimental Group · 1 Intervention: Nalmefene · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nalmefene
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-administration

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
710 Previous Clinical Trials
1,170,731 Total Patients Enrolled
23 Trials studying Alcoholic Intoxication
12,681 Patients Enrolled for Alcoholic Intoxication
Vijay A Ramchandani, Ph.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
7 Previous Clinical Trials
1,246 Total Patients Enrolled
2 Trials studying Alcoholic Intoxication
370 Patients Enrolled for Alcoholic Intoxication

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.