An fMRI Study of Opioid-related Changes in Neural Activity

N/ACompletedNCT02818036

Tristen Inagaki82 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Social Acceptance

Interventions

NaltrexoneDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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