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The Effects of Fentanyl Abuse on Executive Function and Related Brain Activity

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ClinicalTrials.gov Identifier: NCT05469217
Recruitment Status : Not yet recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Ariel University

Brief Summary:
There is a widespread abuse of prescription opioids and a dramatic increase in the availability of illicit opioids. These have created the "opioid epidemic" which is one of the most severe public health crisis in US History. Fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine, is a schedule II prescription drug used to treat severe pain. It is also a drug of abuse. Fentanyl is more likely to cause an overdose than is heroin because of its greater potency. In addition, it has a shorter half-life than most other opioids, causing the high to fade more quickly, requiring opioid drug abusers to inject more frequently, and increasing the risk of overdose. There is an increasing use of Fentanyl in Israel, and one of the treatment centers has reported that on average each month over the last year 10 patients that have used fentanyl were admitted. We propose to investigate executive function using established tasks such as the N-back and Go No Go tasks as well as structural brain imaging of gray matter volume and white matter tracts in 15 fentanyl abuse patients that will be compared with 15 healthy control participants.

Condition or disease Intervention/treatment
Fentanyl Dependence Other: fMRI brain imaging

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effects of Fentanyl Abuse on Executive Function and Related Brain Activity
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Fentanyl dependent patients
15 participants who were treated for fentanyl dependence in treatment centers in Israel
Other: fMRI brain imaging
Structural MRI of gray and white matter, functional MRI during performance of the N-back task

Control participants
Healthy control participants from the general public
Other: fMRI brain imaging
Structural MRI of gray and white matter, functional MRI during performance of the N-back task




Primary Outcome Measures :
  1. Gray matter volume in fMRI [ Time Frame: 2 years ]
    Measures of gray matter volume in MRI

  2. White matter volume in fMRI [ Time Frame: 2 years ]
    Measures of white matter tracts in DTI in MRI

  3. Executive function [ Time Frame: 2 years ]
    Measures of brain activity on the N-Back task in fMRI


Secondary Outcome Measures :
  1. N-back [ Time Frame: 2 years ]
    Measures of performance on the N-Back task in fMRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
15 patients diagnosed with Fentanyl dependence will be recruited from treatment centers and 15 healthy control participants will be recruited from the general public
Criteria

Inclusion Criteria: patients with Fentanyl dependence who have used the drug over the past year - Exclusion Criteria: Neurological impairment, Infectious diseases such as HIV/AIDS, pregnant women, underage, cocaine or alcohol abuse

Healthy control participants from the general public Exclusion Criteria: Neurological impairment, Infectious diseases such as HIV/AIDS, pregnant women, underage, cocaine or alcohol abuse

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05469217


Contacts
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Contact: Aviv M Weinstein, Ph.D +972524307610 avivweinstein@yahoo.com
Contact: Abigail Livny, Ph.d +972549988058 abigail.livnyezer@gmail.com

Sponsors and Collaborators
Ariel University
Sheba Medical Center
Investigators
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Principal Investigator: Galia Zarfati, MD Sheba Tel Hashomer Medical Center
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Responsible Party: Ariel University
ClinicalTrials.gov Identifier: NCT05469217    
Other Study ID Numbers: SMC-9459-22
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ariel University:
Fentanyl, gray matter, white matter, VBM, N-Back