← Back to Search

Opioid Antagonist

Naltrexone for Social Connection

Phase < 1
Recruiting
Led By Tristen Inagaki, PhD
Research Sponsored by San Diego State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, approximately 60 mins after taking study drug
Awards & highlights

Study Summary

This trial is testing the effect of naltrexone, an opioid antagonist, on social connection. It is a randomized, placebo-controlled design, meaning that participants are assigned to either take naltrexone or a placebo (a "sugar pill" with no active ingredient) for 7 days. The participants will complete reports of their feelings of social connection and mood each day, and will also 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.

Who is the study for?
This trial is for English-speaking individuals in good health who are willing to share contact info of close friends, provide photos of loved ones, own a smartphone, and aren't pregnant. It's not for those with BMI over 35, metal implants, claustrophobia, regular prescription medication use, positive drug tests or excessive alcohol use.Check my eligibility
What is being tested?
The study examines the effects of naltrexone (an opioid blocker) on social connection feelings compared to a placebo. Participants take either naltrexone or placebo daily for a week and report their mood and social experiences. On the last day, they undergo an MRI scan while performing tasks that evoke social feelings.See study design
What are the potential side effects?
Participants may experience side effects from naltrexone such as nausea, headache, dizziness or fatigue. Daily physical symptom questionnaires will track any adverse reactions during the trial period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, approximately 60 mins after taking study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, approximately 60 mins after taking study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
Daily feelings of social connection via ecological momentary assessment
feelings in response to neuroimaging tasks
Secondary outcome measures
physical symptoms via daily diary

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NaltrexoneExperimental Treatment1 Intervention
50mg naltrexone HCL once daily for seven days by mouth
Group II: placeboPlacebo Group1 Intervention
sugar pill once daily for seven days by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone Hydrochloride
2021
Completed Phase 1
~330

Find a Location

Who is running the clinical trial?

San Diego State UniversityLead Sponsor
157 Previous Clinical Trials
116,154 Total Patients Enrolled
Tristen Inagaki, PhDPrincipal InvestigatorSan Diego State University

Media Library

Naltrexone Hydrochloride (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05007561 — Phase < 1
Placebo Research Study Groups: Naltrexone, placebo
Placebo Clinical Trial 2023: Naltrexone Hydrochloride Highlights & Side Effects. Trial Name: NCT05007561 — Phase < 1
Naltrexone Hydrochloride (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05007561 — Phase < 1
~85 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top