An fMRI Study of Opioid-related Changes in Neural Activity

Social Acceptance Clinical Trial

Official title:

An fMRI Study of Opioid-related Changes in Neural Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818036
• Other study ID #: PRO15010292
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 21, 2018

Study information

• Verified date: July 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• good health

• between the ages of 18 and 35,

• fluent in English

• right-handed (for the fMRI scan)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Social Acceptance

Intervention

Drug:
• Naltrexone

• Placebo

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tristen Inagaki

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	approximately one hour after taking study drug
Primary	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.	approximately two hours after taking study drug