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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
153 Previous Clinical Trials
86,271 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being accepted into this clinical exploration?

"As per the requirements for this study, participants ought to be between 18 and 25 years of age."

Answered by AI

What other research projects have utilized Naltrexone Hydrochloride as a focus?

"Currently, 45 trials actively researching Naltrexone Hydrochloride exist with 12 of them in the third phase. Most research is conducted within New york City, however there are a total of 160 sites that have studies running on this drug."

Answered by AI

What medical conditions does Naltrexone Hydrochloride typically seek to address?

"Naltrexone Hydrochloride is regularly prescribed for long-term weight control therapies. In addition, it has been used to reduce pain and increase physical activity when combined with a reduced-calorie diet."

Answered by AI

How many individuals are eligible to participate in this trial?

"Affirmative. The clinical trial website confirms that this research study is currently enrolling participants. It was initially posted on November 16th 2021 and its most recent update occurred on March 9th 2022, with the aim of selecting 210 participants from a single medical facility."

Answered by AI

Are there any available openings in this clinical study?

"According to clinicaltrials.gov, this research is open for recruitment. Originally posted on November 16th 2021 and most recently amended on March 9th 2022, the experiment requires participants."

Answered by AI

Are there certain individuals that are more suitable for this medical study?

"To meet the criteria for this trial, individuals must be aged between 18 and 25 years old and have access to naltrexone. This research is looking at recruiting a cohort of 210 people."

Answered by AI

Who else is applying?

What state do they live in?
Alberta
What site did they apply to?
San Diego State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
Tristen Inagaki 2021. "Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05007561.
~93 spots leftby Apr 2026
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