Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Naltrexone Hydrochloride, Placebo.
- Who it may be relevant to
- Registry conditions: Naltrexone, Placebo. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Naltrexone Hydrochloride
oral naltrexone - Drug Placebo
oral sugar pill
Primary outcome measures
- Daily feelings of social connection via ecological momentary assessment [Time frame: post-treatment, change across 7 days]
- Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs [Time frame: Day 7, approximately 60 mins after taking study drug]
- feelings in response to neuroimaging tasks [Time frame: Day 7, approximately 150 minutes after taking study drug]
Secondary outcome measures (1)
- physical symptoms via daily diary [Time frame: end of day on days 1-7]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- San Diego State University — San Diego
Identifiers
NCT: NCT05007561 · HS-2020-0188-SMT · R01DA052883