An fMRI Study of Opioid-related Changes in Neural Activity

July 17, 2019 updated by: Tristen Inagaki
The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: naltrexone
single 50mg dose of naltrexone
Drug: Naltrexone
Placebo Comparator: sugar pill
single sugar pill
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
Time Frame: 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).
approximately one hour after taking study drug
Self-reported Feelings of Connection in Response to the Scanner Tasks
Time Frame: 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.
approximately two hours after taking study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tristen Inagaki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

June 21, 2018

Study Completion (Actual)

June 21, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO15010292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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