Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Naltrexone 50mg naltrexone HCL once daily for seven days by mouth |
Drug: Naltrexone Hydrochloride
oral naltrexone
Other Names:
|
| Placebo Comparator: placebo sugar pill once daily for seven days by mouth |
Drug: Placebo
oral sugar pill
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Daily feelings of social connection via ecological momentary assessment [post-treatment, change across 7 days]
State feelings of social connection outside of the lab
- Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs [Day 7, approximately 60 mins after taking study drug]
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).
- feelings in response to neuroimaging tasks [Day 7, approximately 150 minutes after taking study drug]
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)
Secondary Outcome Measures
- physical symptoms via daily diary [end of day on days 1-7]
Physical symptoms previously associated with naltrexone will be assessed as well as the subjective experience of the symptoms.
Eligibility Criteria
Criteria
Inclusion Criteria:
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good health
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English fluency
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willing to provide contact information for 4-6 close others
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willing to provide digital photographs of 2 close others
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own a smartphone
Exclusion Criteria:
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presence of medical devices, implants, or other metal objects in or on the body that cannot be removed
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tattooed eyeliner
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a body habitus prohibiting MRI scanning
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claustrophobia
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self-reported chronic mental or physical illness
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current and regular use of prescription medication
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previous history of having difficulty taking pills
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current use of opioid analgesics
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depressive symptoms above a 9 on Patient Health Questionnaire
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excessive alcohol use
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positive urine drug test
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body mass index (BMI) greater than 35
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pregnancy or plans to become pregnant in next 6 months
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positive urine pregnancy test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Diego State University | San Diego | California | United States | 92120 |
Sponsors and Collaborators
- San Diego State University
Investigators
- Principal Investigator: Tristen Inagaki, PhD, San Diego State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01DA052883