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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05007561
Other study ID # R01DA052883
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date November 16, 2021
Est. completion date July 2026

Study information

Verified date April 2024
Source San Diego State University
Contact Tristen Inagaki, PhD
Phone 6195941058
Email tinagaki@sdsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date July 2026
Est. primary completion date April 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naltrexone Hydrochloride
oral naltrexone
Placebo
oral sugar pill

Locations

Country Name City State
United States San Diego State University San Diego California

Sponsors (1)

Lead Sponsor Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily feelings of social connection via ecological momentary assessment State feelings of social connection outside of the lab post-treatment, change across 7 days
Primary 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
Primary 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 physical symptoms via daily diary Physical symptoms previously associated with naltrexone will be assessed as well as the subjective experience of the symptoms. end of day on days 1-7
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