RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-16
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05007561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * good health
  2. * English fluency
  3. * willing to provide contact information for 4-6 close others
  4. * willing to provide digital photographs of 2 close others
  5. * own a smartphone
  1. * presence of medical devices, implants, or other metal objects in or on the body that cannot be removed
  2. * tattooed eyeliner
  3. * a body habitus prohibiting MRI scanning
  4. * claustrophobia
  5. * self-reported chronic mental or physical illness
  6. * current and regular use of prescription medication
  7. * previous history of having difficulty taking pills
  8. * current use of opioid analgesics
  9. * depressive symptoms above a 9 on Patient Health Questionnaire
  10. * excessive alcohol use
  11. * positive urine drug test
  12. * body mass index (BMI) greater than 35
  13. * pregnancy or plans to become pregnant in next 6 months
  14. * positive urine pregnancy test

Contacts and Locations

Study Contact

Tristen Inagaki, PhD
CONTACT
6195941058
tinagaki@sdsu.edu

Principal Investigator

Tristen Inagaki, PhD
PRINCIPAL_INVESTIGATOR
San Diego State University

Study Locations (Sites)

San Diego State University
San Diego, California, 92120
United States

Collaborators and Investigators

Sponsor: San Diego State University

  • Tristen Inagaki, PhD, PRINCIPAL_INVESTIGATOR, San Diego State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-16
Study Completion Date2026-07

Study Record Updates

Study Start Date2021-11-16
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Naltrexone
  • Placebo