Opioid Modulation and Neural Reward Activation in Healthy Adults

University of Colorado, Denver13 enrolled

Overview

This is a double blind study of the effects of opioid antagonism on the brain's reward response. The investigators will recruit participants to undergo two scans, one on active medication and one on placebo. During the scan, the investigators will assess reward.

The study will employ a crossover design. The study will use the monetary incentive delay task during functional MRI to assess reward. This task presents participants with cues indicating whether they are playing to win $5, win $0, or to avoid losing $5. This task has been well-validated to elicit activation in a key reward response area of the brain called the ventral striatum.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Alcohol Drinking Opioid Use, Unspecified

Interventions

NaltrexoneDRUG

Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.

PlaceboOTHER

Placebo will be used to control for expectancy effects

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Between 18 and 35 years of age, * Is a moderate drinker (i.e. consumes 1-14 drinks/week for males, or 1-7 drinks/week for females). Exclusion Criteria: * Non-drinker * Positive result on urine drug screen or breathalyzer at the start of any study visit * Inability to complete MRI (e.g. presence of ferromagnetic objects in body) * Current use of medications that alter the hemodynamic response such as insulin * History of trauma resulting in loss of consciousness longer than 15 minutes * Currently taking opioid medications * Pregnancy

Locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in Brain Activation to Reward Between Placebo and Active Medication

Percent signal change relative to baseline in the nucleus accumbens during cue to win $5 as assessed during functional MRI. Higher values of percent signal change indicate greater activation to reward. We will compare the active medication condition to the placebo, establishing whether there is a difference between the conditions.

Time frame: one week

Secondary Outcomes

Alcohol Value

Maximum alcohol expenditure, or Omax, is the maximum amount of money that a person will pay for alcohol in a hypothetical alcohol consumption task called the "Alcohol Purchase Task". Higher values of Omax indicate that a person values consuming alcohol at a greater level.

Time frame: one week

Brain Activation to Emotion Regulation

Percent signal change from baseline in the amygdala during trials to regulate emotion relative to trials to passively experience emotion during a functional MRI scan. Cues will be negative images, and instructions will be either "decrease" or "look".

Time frame: one week

Data from ClinicalTrials.gov

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