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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04854551
Other study ID # 21-2886
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 1, 2021
Est. completion date April 18, 2022

Study information

Verified date November 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date April 18, 2022
Est. primary completion date April 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naltrexone
Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.
Other:
Placebo
Placebo will be used to control for expectancy effects

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one week
Secondary 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. one week
Secondary 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". one week
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