Opioid Modulation and Neural Reward Activation in Healthy Adults

Alcohol Drinking Clinical Trial

Official title:

Opioid Modulation and Neural Reward Activation in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854551
• Other study ID #: 21-2886
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Opioid Use, Unspecified

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