An fMRI Study of Opioid-related Changes in Neural Activity
NCT ID: NCT02818036
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2016-08-31
2018-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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naltrexone
single 50mg dose of naltrexone
Naltrexone
sugar pill
single sugar pill
Placebo
Interventions
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Naltrexone
Placebo
Eligibility Criteria
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Inclusion Criteria
* between the ages of 18 and 35,
* fluent in English
* right-handed (for the fMRI scan)
Exclusion Criteria
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Tristen Inagaki
OTHER
Responsible Party
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Tristen Inagaki
Assistant Professor
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO15010292
Identifier Type: -
Identifier Source: org_study_id
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