An fMRI Study of Opioid-related Changes in Neural Activity

NCT02818036 | Completed Results

• 1 other identifier: PRO15010292
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Social Acceptance

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

naltrexone

EXPERIMENTAL

single 50mg dose of naltrexone

Drug: Naltrexone

sugar pill

PLACEBO COMPARATOR

single sugar pill

Drug: Placebo

Interventions

Naltrexone DRUG

naltrexone

Placebo DRUG

sugar pill

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good health
• between the ages of 18 and 35,
• fluent in English
• right-handed (for the fMRI scan)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tristen Inagaki: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (2)

• Ross LP, Andreescu C, Inagaki TK. Relationships Between Early Maternal Warmth and Social Connection: A Randomized Clinical Trial With Naltrexone. Psychosom Med. 2021 Oct 1;83(8):924-931. doi: 10.1097/PSY.0000000000000986.

  PMID: 34292204 DERIVED

• Inagaki TK, Hazlett LI, Andreescu C. Opioids and social bonding: Effect of naltrexone on feelings of social connection and ventral striatum activity to close others. J Exp Psychol Gen. 2020 Apr;149(4):732-745. doi: 10.1037/xge0000674. Epub 2019 Aug 15.

  PMID: 31414860 DERIVED

MeSH Terms

Interventions

Naltrexone

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Tristen Inagaki
• Organization: University of Pittsburgh

inagaki@pitt.edu

412-624-4211

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 29, 2016
• Study Start: August 1, 2016
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07

Locations

US (1)