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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2027-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Naltrexone Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Naltrexone

50mg naltrexone HCL once daily for seven days by mouth

Group Type EXPERIMENTAL

Naltrexone Hydrochloride

Intervention Type DRUG

oral naltrexone

placebo

sugar pill once daily for seven days by mouth

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral sugar pill

Interventions

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Naltrexone Hydrochloride

oral naltrexone

Intervention Type DRUG

Placebo

oral sugar pill

Intervention Type DRUG

Other Intervention Names

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oral naltrexone naltrexone pill naltrexone naltrexone oral tablet sugar pill

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes