Opioid Modulation and Neural Reward Activation in Healthy Adults

Opioid Modulation and Neural Reward Activation in Healthy Adults

Sponsors

Lead Sponsor: University of Colorado, Denver

Source University of Colorado, Denver
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.

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.

Overall Status Active, not recruiting
Start Date 2021-05-01
Completion Date 2022-04-30
Primary Completion Date 2022-04-30
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Brain activation to reward one week
Secondary Outcome
Measure Time Frame
Alcohol value one week
Brain activation to emotion regulation one week
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: Naltrexone

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

Intervention Type: Other

Intervention Name: Placebo

Description: Placebo will be used to control for expectancy effects

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

35 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Joshua Gowin, PhD

Phone: 3037243769

Email: [email protected]

Location
Facility: University of Colorado Anschutz Medical Campus
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Healthy adults: placebo first

Type: Experimental

Description: This arm will receive placebo first, then active medication second

Label: Healthy adults: active medication first

Type: Experimental

Description: This arm will receive active medication first, then placebo second

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Participants will be counterbalanced for the order they undergo placebo and medication.

Primary Purpose: Basic Science

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: capsule, double blind

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News