NCT05007561

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: San Diego State University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.

Conditions

• Naltrexone
• Placebo

Interventions

Type	Name	Description
DRUG	Naltrexone Hydrochloride	oral naltrexone
DRUG	Placebo	oral sugar pill

Timeline

• Start date: 2021-11-16
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2021-08-16
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study