Opioid Modulation and Neural Reward Activation in Healthy Adults

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT04854551

Collaborator

(none)

Enrollment

Location

Arms

11.6

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking Opioid Use, Unspecified	Drug: Naltrexone Other: Placebo	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will be counterbalanced for the order they undergo placebo and medication.Participants will be counterbalanced for the order they undergo placebo and medication.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

capsule, double blind

Primary Purpose:

Basic Science

Official Title:

Opioid Modulation and Neural Reward Activation in Healthy Adults

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Apr 18, 2022

Actual Study Completion Date :

Apr 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy adults: placebo first This arm will receive placebo first, then active medication second	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
Experimental: Healthy adults: active medication first This arm will receive active medication first, then placebo second	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

Arm

Intervention/Treatment

Experimental: Healthy adults: placebo first

This arm will receive placebo first, then active medication second

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

Experimental: Healthy adults: active medication first

This arm will receive active medication first, then placebo second

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

Outcome Measures

Primary Outcome Measures

Brain activation to reward [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.

Secondary Outcome Measures

Alcohol value [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.
Brain activation to emotion regulation [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04854551

Other Study ID Numbers:

21-2886

First Posted:

Apr 22, 2021

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Alcohol Drinking

Naltrexone

Study Results

No Results Posted as of Aug 12, 2022