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

NCT05007561 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: HS-2020-0188-SMTR01DA052883
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Daily feelings of social connection via ecological momentary assessment

  State feelings of social connection outside of the lab

  post-treatment, change across 7 days

• Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs

  In the MRI scanner, participants read sentences written by people they know and people they do not know in a block design. In a second task they view images of people they know, those they do not know, and other emotional images. Brain activity will be measured as BOLD activity in response to stimuli from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity will be masked to activity in structural regions-of- interest (ROIs) of the ventral striatum (VS), middle-insula (MI), anterior cingulate cortex (ACC) and ventromedial prefrontal cortex (VMPFC).

  Day 7, approximately 60 mins after taking study drug

• feelings in response to neuroimaging tasks

  Feelings of social connection and general positive affect in response to the neuroimaging tasks will be reported on a scale of 1 (not at all) to 7 (very)

  Day 7, approximately 150 minutes after taking study drug

Secondary Outcomes (1)

• physical symptoms via daily diary

  end of day on days 1-7

Study Arms (2)

Naltrexone

EXPERIMENTAL

50mg naltrexone HCL once daily for seven days by mouth

Drug: Naltrexone Hydrochloride

placebo

PLACEBO COMPARATOR

sugar pill once daily for seven days by mouth

Drug: Placebo

Interventions

Naltrexone Hydrochloride DRUG

oral naltrexone

Also known as: oral naltrexone, naltrexone pill, naltrexone, naltrexone oral tablet

Naltrexone

Placebo DRUG

oral sugar pill

Also known as: sugar pill

placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good health
• English fluency
• willing to provide contact information for 4-6 close others
• willing to provide digital photographs of 2 close others
• own a smartphone

You may not qualify if:

• presence of medical devices, implants, or other metal objects in or on the body that cannot be removed
• tattooed eyeliner
• a body habitus prohibiting MRI scanning
• claustrophobia
• self-reported chronic mental or physical illness
• current and regular use of prescription medication
• previous history of having difficulty taking pills
• current use of opioid analgesics
• depressive symptoms above a 9 on Patient Health Questionnaire
• excessive alcohol use
• positive urine drug test
• body mass index (BMI) greater than 35
• pregnancy or plans to become pregnant in next 6 months
• positive urine pregnancy test

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92120, United States

RECRUITING

MeSH Terms

Interventions

Naltrexone; Sugars

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Carbohydrates

Study Officials

• Tristen Inagaki, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tristen Inagaki, PhD

CONTACT

6195941058; tinagaki@sdsu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 16, 2021
• Study Start: November 16, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: After publication of the primary findings.
• Access Criteria: Researchers in both private and public sector

Locations

US (1)