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Completed

NCT Number: NCT02818036

An fMRI Study of Opioid-related Changes in Neural Activity

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

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Key information

Conditions

Social Acceptance

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

Drug

Placebo

Drug

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Tristen Inagaki

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2016
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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