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

Placebo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05007561
• Other study ID #: R01DA052883
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Naltrexone
• Placebo

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