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

Part of paid clinical trials in San Diego, California.

Sponsor
San Diego State University
Study ID
NCT05007561
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Naltrexone
  • Placebo

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Naltrexone Hydrochloride — DRUG
    oral naltrexone
  • Placebo — DRUG
    oral sugar pill

Study Details

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.

Key Dates

Start date
Nov 16, 2021
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Naltrexone
    50mg naltrexone HCL once daily for seven days by mouth
  • Placebo Comparator: placebo
    sugar pill once daily for seven days by mouth

Primary Outcome Measure

Daily feelings of social connection via ecological momentary assessment [ Time Frame: post-treatment, change across 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Diego State UniversitySan DiegoCalifornia92120
Tristen Inagaki, PhD

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San Diego State University· San Diego, CA

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