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NCT05007561EARLY_PHASE1RecruitingAccepts Healthy Volunteers

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

San Diego State University

Start Date

11/16/2021

Completion Date

7/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 25 years

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

Interventions

DRUG

Naltrexone Hydrochloride

DRUG

Placebo

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Conditions

NaltrexonePlacebo

Locations

San Diego State University

San Diego, California 92120

United States