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OpenTrials
Completed

NCT Number: NCT04854551

Opioid Modulation and Neural Reward Activation in Healthy Adults

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Opioid Use, Unspecified

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

Drug

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

Placebo

Other

Placebo will be used to control for expectancy effects

Primary outcomes

  1. Change in Brain Activation to Reward Between Placebo and Active Medication

    Time frame: one week

    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.

Secondary outcomes

  1. Alcohol Value

    Time frame: one week

    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.

  2. Brain Activation to Emotion Regulation

    Time frame: one week

    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".

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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