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Opioid Physiology Project (OPP)

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ClinicalTrials.gov Identifier: NCT03462797
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:
The current project seeks to explore the use of emergent biosensor technology to detect opioid use. The investigators goal is to recruit 60 opioid naïve patients presenting at the College of Dentistry at UTHSC. Candidate participants must be scheduled for an upcoming dental procedure that will involve subsequent pain management using oral opioid medication. Participants will be consented prior to any study procedures. All participant information from this study will be kept strictly confidential (e.g., no individual data will be shared with the College of Dentistry).

Condition or disease
Tolerance Withdrawal Addiction Epigenetic Changes

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Opioid Physiology Project
Actual Study Start Date : August 14, 2017
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018



Primary Outcome Measures :
  1. Physiological changes [ Time Frame: Physiological activity recording will start 24 to 48 hours before dental surgery date. Physiological activity will be stopped 2 days after discontinuation of opioid self-administration and will not exceed 30 days from surgery date. ]

    We will be measuring physiological changes from pre- to post-opioid administration through the Empatica E4 electronic wristband. This device measures 5 physiological parameters:

    1. Physical activity through an accelerometer measuring movement on x,y, and z axes.
    2. Heart rate measured in beats per minute (BMP)
    3. Skin conductance measured in µs (microseconds)
    4. Temperature measured in Celsius (°C)
    5. Blood volume pulse measured in nm (nanometers)

    and DNA methylation after self administration of opioid medication.



Secondary Outcome Measures :
  1. DNA Methlyation changes [ Time Frame: Initial saliva sample will be collected before surgery date. Second sample will be collected 2 days after discontinuation of opioid self-administration. Last sample will be collected at the 30 days from surgery date. ]
    We will be measuring DNA methylation markers and their changes from pre- to post-opioid administration through Ilumina Infinium methylation EPIC. More specifically, we will be looking at changes in β-values, which are the ratio of (DNA methylation)/(DNA methylation + DNA unmethylation). We will use DNA Genotek's Oragene Discover for saliva collection.


Biospecimen Retention:   Samples With DNA
The coordinator will collect saliva samples (ORG-500) from study subjects at the start of study and at follow up visits. Saliva samples will be collected non-invasively using the DNA Oragene sample collection kits (http://www.dnagenotek.com). The investigator will then perform genome-wide DNA methylation assay using the Illumina Infinium MethylationEPIC array (https://www.illumina.com). The investigator will monitor the longitudinal change in the methylome that may be induced by short-term opioid use.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Our study population will be recruited for the University of Tennessee College of Dentistry. Recruited populations will be opioid naive individuals that are scheduled for an upcoming dental surgery that will result in an opioid medication be prescribed for pain management.
Criteria

Inclusion Criteria:

  • Adult (18 or over)
  • Opioid naive
  • Getting a dental surgery where clinicians will prescribe opioid medication
  • Ability to consent
  • English as primary language
  • Willingness to wear biosensor
  • Willingness to complete daily log
  • Willingness to provide saliva samples (epigenetics)

Exclusion Criteria:

  • Inability to wear biosensor
  • Other cause of pain (that may lead to other opioid use)
  • Current drug or alcohol depend
  • Inability to Consent
  • Pregnancy
  • Incarceration
  • Musculoskeletal causes of pain limiting motion
  • Upper Extremity Amputation
  • Individuals with Developmental Disabilities

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): NCT03462797


Locations
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United States, Tennessee
University of Tennessee College of Dentistry
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: Karen J Derefinko, PhD University of Tennessee Health Science Center
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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT03462797    
Other Study ID Numbers: 17-05380-XP
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
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
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior