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Report for Clinical Trial NCT02639273

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02639273 AUD
MeSH:Alcoholic Intoxication

2 Interventions

Name: Nalmefene

Description: Active Drug
Type: Drug
Group Labels: 1


Name: Placebo

Description: Single Dose Placebo
Type: Other
Group Labels: 1


Primary Outcomes

Description: functional MRI measure of brain activation.

Measure: Nalmefene-induced BOLD signal changes in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula

Time: Post-administration

Description: human laboratory alcohol consumption measure.

Measure: Nalmefene-induced changes in IV alcohol self-administration

Time: Post-administration

Secondary Outcomes

Description: functional MRI measure of brain activation.

Measure: Nalmefene-induced BOLD signal changes in neural processing of aversive stimuli during fMRI

Time: Post-adminstration

Description: human laboratory alcohol consumption measure.

Measure: Genotypic modulation (at the OPRM1 118 location) of Nalmafene's effects on primary outcome measures (BOLD signal change during alcohol reward processing and IV alcohol self-administration).

Time: Post-administration

Purpose: Other

Allocation: Randomized

Crossover Assignment

There is one SNP


1 A118G

Genetic variation at the micro-opioid receptor gene locus, OPRM1, specifically the A118G polymorphism, is associated with differential subjective responses to alcohol. --- A118G ---

Further, the A118G polymorphism has been shown to moderate the effect of opioid receptor modulators on alcohol consumption. --- A118G ---

However, the role of A118G on nalmefene s effectivenes, and the neural substrates underlying nalmefene s therapeutic effect remain to be explored in humans. --- A118G ---

Objective: To evaluate the effect of nalmefene on alcohol self-infusion and neural response to alcohol cues in healthy male and female heavy drinkers, and to examine the role of the OPRM1 A118G polymorphism on this effect. --- A118G ---

HPO Nodes