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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA052883 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone | Experimental | 50mg naltrexone HCL once daily for seven days by mouth |
|
| placebo | Placebo Comparator | sugar pill once daily for seven days by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone Hydrochloride | Drug | oral naltrexone |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily feelings of social connection via ecological momentary assessment | State feelings of social connection outside of the lab | post-treatment, change across 7 days |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tristen Inagaki, PhD | Contact | 6195941058 | tinagaki@sdsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tristen Inagaki, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego State University | Recruiting | San Diego | California | 92120 | United States |
Data and resources from the current study will be deposited in the Open Science Framework (OSF) and OpenNEURO.org, in accordance with the NIH Data Sharing Policy. In addition, results will be posted on the ClinicalTrials.gov website within 1 year of the study's completion date.
After publication of the primary findings.
Researchers in both private and public sector
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo | Drug | oral sugar pill |
|
|
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |