An interventional study of Naltrexone and Placebo in Social Acceptance, sponsored by Tristen Inagaki. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Tristen Inagaki · Not applicable, Interventional, and Basic science
The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.
This is the only study on the registry with Tristen Inagaki as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single 50mg dose of naltrexone
Drug: Naltrexone
single sugar pill
Drug: Placebo
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
In the MRI scanner, participants read sentences written by people they knew and people they did not know in a block design. Brain activity was measured as BOLD activity in response to reading sentences from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity was masked to activity in structural regions-of-interest (ROIs) of the ventral striatum (VS) and middle-insula (MI).
Time frame: approximately one hour after taking study drug
Self-reported Feelings of Connection in Response to the Scanner Tasks
feelings of social connection in response to reading sentences from known people (i.e. average of how connected, touched, warm did you feel). Feelings were reported on a scale of 1 (not at all) to 7 (very) such that higher numbers reflect greater feelings of social connection. time frame was mistakenly entered as the start of the fMRI scan, but participants reported on their feelings of social connection after the scan. Thus, the outcome measure time frame is reported as two, rather than one, hour after taking the study drug.
Time frame: approximately two hours after taking study drug
| Milestone | Naltrexone | Sugar Pill |
|---|---|---|
| Started | 42 | 40 |
| Completed | 40 | 40 |
| Not completed | 2 | 0 |
| Withdrew: Head did not fit in fmri scanner headres | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
In the MRI scanner, participants read sentences written by people they knew and people they did not know in a block design. Brain activity was measured as BOLD activity in response to reading sentences from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity was masked to activity in structural regions-of-interest (ROIs) of the ventral striatum (VS) and middle-insula (MI).
| BOLD signal | Naltrexone | Sugar Pill |
|---|---|---|
| Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs | 0.117 ± 0.033 | 0.2545 ± 0.061 |
feelings of social connection in response to reading sentences from known people (i.e. average of how connected, touched, warm did you feel). Feelings were reported on a scale of 1 (not at all) to 7 (very) such that higher numbers reflect greater feelings of social connection. time frame was mistakenly entered as the start of the fMRI scan, but participants reported on their feelings of social connection after the scan. Thus, the outcome measure time frame is reported as two, rather than one, hour after taking the study drug.
| scores on a scale | Naltrexone | Sugar Pill |
|---|---|---|
| Self-reported Feelings of Connection in Response to the Scanner Tasks | 4.576 ± .848 | 4.766 ± .895 |
Collected over Symptoms in response to taking the study drugs were collected approximately three hours after drug administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naltrexone | 0/40 (0%) | 0/40 (0%) | 30/40 (75%) |
| Sugar Pill | 0/40 (0%) | 0/40 (0%) | 20/40 (50%) |
| Event | Naltrexone | Sugar Pill |
|---|---|---|
| FatigueGeneral disorders | 28/40 | 19/40 |
| DizzinessNervous system disorders | 15/40 | 4/40 |
| HeadacheNervous system disorders | 10/40 | 5/40 |
| NauseaGastrointestinal disorders | 6/40 | 3/40 |
| Stomach painGastrointestinal disorders | 4/40 | 3/40 |
2 participants were not included from the naltrexone group for final analyses
| Age, Continuous(years) | Naltrexone | Sugar Pill | Total |
|---|---|---|---|
| Mean | 21.90 ± 3.49 | 22.88 ± 3.20 | 22.39 ± 3.362 |
| Sex: Female, Male(Participants) | Naltrexone | Sugar Pill | Total |
|---|---|---|---|
| Female | 27 | 21 | 48 |
| Male | 13 | 19 | 32 |
| Race (NIH/OMB)(Participants) | Naltrexone | Sugar Pill | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 12 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 27 | 23 | 50 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Body Mass Index (BMI)(kg/m^2) | Naltrexone | Sugar Pill | Total |
|---|---|---|---|
| Mean | 24.30 ± 3.60 | 23.42 ± 2.61 | 23.86 ± 3.15 |
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