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Completed Phase 1 Interventional Accepts healthy volunteers

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 ID: NCT02639273

Public ClinicalTrials.gov record NCT02639273. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Background: Drugs like nalmefene interfere with opioid receptors. This might reduce drinking. The gene OPRM1 determines opioid receptor functions. Researchers want to see if nalmefene affects people s responses to alcohol cues. They also want to compare how nalmefene affects people with different forms of OPRM1. Objectives: To test nalmefene s effects on alcohol self-infusion and responses to alcohol cues. To test the role of different forms of OPRM1 on these effects. Eligibility: Healthy heavy drinkers ages 21 60: Women: over 15 drinks weekly Men: over 20 drinks weekly Design: Participants will be screened with: Medical history Physical exam Heart, blood, and urine tests Questionnaires Participants will have three 10-hour visits and one 2-hour follow-up visit. They will take a taxi. Visits are about 1 week apart. Before visits, participants cannot drink alcohol for 1 day or take medicine for 3 days. All study visits: Questionnaires Heart monitor Two-hour alcohol session: A needle guides a thin plastic tube into a vein in each arm. One tube receives alcohol. The other draws blood. Participants give themselves alcohol by pressing a button on a computer. Relaxing at the center until breath alcohol falls below 0.02 percent, or for 3 hours. Visits 2 and 3: Swallowing nalmefene or placebo. One-hour brain MRI: Participants lie on a table with a coil on their head. They press buttons in response to computer cues. Follow-up visit: participants will discuss their drinking habits.

Study identification

NCT ID
NCT02639273
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
13 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
21 Years to 60 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 7, 2016
Primary completion
Dec 7, 2023
Completion
Dec 7, 2023
Last update posted
Aug 30, 2026

2016 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02639273, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 30, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02639273 live on ClinicalTrials.gov.

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