Actively Recruiting

Early Phase 1
Age: 18Years - 25Years
All Genders
Healthy Volunteers
ID05007561

Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences

Led by San Diego State University · Updated on 2026-04-13

210

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

S

San Diego State University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how opioids influence both the experience and brain activity related to social connections. This early phase 1 trial uses a randomized, placebo-controlled design to compare the effects of the opioid blocker oral naltrexone with a placebo in adults aged 18 to 25 years. The goal is to understand natural feelings of social connection and mood in daily life and during social tasks in the brain scanner. Participants receive either 50 mg of naltrexone or a sugar pill once daily for seven days. During this period, they report their feelings of social connection and mood each day, along with any physical symptoms. On the seventh day, they undergo functional MRI scanning while performing tasks designed to evoke feelings of social connection, followed by assessments of their emotional responses to these tasks. Throughout the study, participants complete daily questionnaires on social feelings and physical symptoms. The study measures changes in social connection over the week using momentary assessments, brain activity patterns during the scan, and responses to the scanner tasks. Safety is monitored by tracking physical symptoms daily. The total participation lasts seven days, including the final day MRI visit and assessments.

CONDITIONS

Brief Title

Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences

Who Can Participate

Age: 18Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be in good health
  • Speak English fluently
  • Be willing to provide contact information for 4 to 6 close others
  • Be willing to provide digital photographs of 2 close others
  • Own a smartphone
  • Be between 18 and 25 years old
Not Eligible

You will not qualify if you...

  • Have medical devices, implants, or metal objects in or on the body that cannot be removed
  • Have tattooed eyeliner
  • Have a body type that prevents MRI scanning
  • Experience claustrophobia
  • Have chronic mental or physical illness
  • Currently use prescription medication regularly
  • Have a history of difficulty taking pills
  • Currently use opioid pain medications
  • Have depressive symptoms scoring above 9 on the Patient Health Questionnaire
  • Use alcohol excessively
  • Have a positive urine drug test
  • Have a body mass index (BMI) over 35
  • Are pregnant or planning to become pregnant in the next 6 months
  • Have a positive urine pregnancy test

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 7 days

Participants take either 50mg of naltrexone hydrochloride or a placebo pill once daily by mouth for seven days.

1 baseline visit and 1 neuroimaging visit on Day 7

Trial Site Locations

Total: 1 location

1

San Diego State University

San Diego, California, United States, 92120

Actively Recruiting

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Research Team

T

Tristen Inagaki, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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