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Opioid Receptor Modulator

Nalmefene for Alcohol Use

Phase 1
Waitlist Available
Led By Vijay A Ramchandani, Ph.D.
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-administration
Awards & highlights

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
  • Auditory Processing Disorder (APD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amygdaloid structure
Nalmefene-induced changes in IV alcohol self-administration
Secondary outcome measures
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).
Nalmefene-induced BOLD signal changes in neural processing of aversive stimuli during fMRI

Side effects data

From 2010 Phase 3 trial • 598 Patients • NCT00811720
28%
Dizziness
27%
Nausea
18%
Fatigue
12%
Nasopharyngitis
12%
Headache
11%
Sleep disorder
10%
Insomnia
8%
Vomiting
5%
Hyperhidrosis
1%
Alcoholism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nalmefene 18.06 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DrugExperimental Treatment1 Intervention
single dose nalmefene
Group II: PlaceboPlacebo Group1 Intervention
single dose placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nalmefene
2016
Completed Phase 3
~2250

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
801 Previous Clinical Trials
1,365,384 Total Patients Enrolled
Vijay A Ramchandani, Ph.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
7 Previous Clinical Trials
1,955 Total Patients Enrolled

Media Library

Nalmefene (Opioid Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT02639273 — Phase 1
Auditory Processing Disorder Research Study Groups: Placebo, Drug
Auditory Processing Disorder Clinical Trial 2023: Nalmefene Highlights & Side Effects. Trial Name: NCT02639273 — Phase 1
Nalmefene (Opioid Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02639273 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies does Nalmefene typically aid in treating?

"Nalmefene is typically prescribed to aid in the abatement of physical withdrawal symptoms. It can also be useful for individuals with a high drinking risk level (DRL), alcohol dependency, and requiring psycosocial support."

Answered by AI

To what extent is this trial recruiting participants?

"Affirmative. The data hosted on clinicaltrials.gov confirms that this medical trial is currently enrolling patients, with the initial posting being made on June 8th 2016. There are 2 locations in participation, each recruiting for 30 participants at this time."

Answered by AI

Please provide a summation of the research conducted on Nalmefene.

"At present, 3 clinical trials concerning the effects of Nalmefene are operational with none at Phase 3. Of these studies, 7 are situated in various regions while a majority is operating from Bethesda, Maryland."

Answered by AI

Does this research project accept participants who are above the age of 50?

"The guidelines for entry into this clinical trial require participants to be between 21 and 60 years of age. There is 1 separate study targeting individuals beneath 18, and 4 tailored specifically towards those over 65."

Answered by AI

What impact will Nalmefene have on the physical and psychological wellbeing of patients?

"There is a paucity of data demonstrating efficacy and safety for Nalmefene, so it received the lowest score (1) on our rating system."

Answered by AI

Are there currently any open slots to participate in this trial?

"Yes, based on the data hosted at clinicaltrials.gov, it is clear that this medical trial has been open for recruitment since June 8th 2016 and was last updated on October 13th 2022. There are 2 sites recruiting a total of 60 participants."

Answered by AI

What are the criteria for joining this medical research initiative?

"To meet the criteria of this trial, patients must have a diagnosis of alcohol intoxication and be between 21 to 60 years old. Currently, our team is seeking up to 60 participants for enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation
2016. "Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02639273.
~1 spots leftby Apr 2025
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