An fMRI Study of Opioid-related Changes in Neural Activity
- Registration Number
- NCT02818036
- Lead Sponsor
- Tristen Inagaki
- Brief Summary
The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- good health
- between the ages of 18 and 35,
- fluent in English
- right-handed (for the fMRI scan)
- Self-reported current or past diagnoses of physical or mental illness.
- Score on the Patient Health Questionnaire (depressive symptoms) above a 13
- Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
- Positive urine pregnancy test
- Use of any prescription medication, except for birth control
- Use of any over-the-counter medications on the day of the fMRI session and 24 hours after the fMRI session
- Self-reported problems with liver functioning, including hepatitis or liver failure
- Difficulty swallowing or taking pills
- BMI greater than 35 or weight greater than 400 lbs
- Claustrophobia
- Nonremovable metal in the body
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description naltrexone Naltrexone single 50mg dose of naltrexone sugar pill Placebo single sugar pill
- Primary Outcome Measures
Name Time Method Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs approximately one hour after taking study drug 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).
Self-reported Feelings of Connection in Response to the Scanner Tasks approximately two hours after taking study drug 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States