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

NCT02639273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

...

Conditions

  • AUD

Interventions

DRUG

Nalmefene

Active Drug

OTHER

Placebo

Single Dose Placebo

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Vijay A Ramchandani, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-08
Primary Completion
2023-12-08
Completion
2023-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639273 on ClinicalTrials.gov