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

• Status: Recruiting
• Trial end date: 2023-12-31

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.

• Phase: Phase 1

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Nalmefene