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NCT Number: NCT05007561

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

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.

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Key information

Conditions

Naltrexone Placebo

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

San Diego State University

San Diego, California, 92120, United States

Location status: Recruiting

Location contact

Tristen Inagaki, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Naltrexone Hydrochloride

Drug

oral naltrexone

Other names: oral naltrexone, naltrexone pill, naltrexone, naltrexone oral tablet

Placebo

Drug

oral sugar pill

Other names: sugar pill

Primary outcomes

  1. Daily feelings of social connection via ecological momentary assessment

    Time frame: post-treatment, change across 7 days

    State feelings of social connection outside of the lab

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

    Time frame: Day 7, approximately 60 mins after taking study drug

    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).

  3. feelings in response to neuroimaging tasks

    Time frame: Day 7, approximately 150 minutes after taking study drug

    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)

Secondary outcomes

  1. physical symptoms via daily diary

    Time frame: end of day on days 1-7

    Physical symptoms previously associated with naltrexone will be assessed as well as the subjective experience of the symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Tristen Inagaki, PhD

CONTACT

[email protected]

6195941058

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2021
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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