An fMRI Study of Opioid-related Changes in Neural Activity

NCT ID: NCT02818036

Last Updated: 2019-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-06-21

Brief Summary

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

Detailed Description

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Conditions

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Social Acceptance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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naltrexone

single 50mg dose of naltrexone

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

sugar pill

single sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Naltrexone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tristen Inagaki

OTHER

Sponsor Role lead

Responsible Party

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Tristen Inagaki

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34292204 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31414860 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PRO15010292

Identifier Type: -

Identifier Source: org_study_id

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