Opioid Physiology Project

NCT03462797 | Completed

• 1 other identifier: 17-05380-XP
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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).

Conditions

Tolerance; Withdrawal; Addiction; Epigenetic Changes

Outcome Measures

Primary Outcomes (1)

• Physiological changes

  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.

  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.

Secondary Outcomes (1)

• DNA Methlyation changes

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee College of Dentistry

Memphis, Tennessee, 38103, United States

Location

Related Publications (1)

• Salgado Garcia FI, Indic P, Stapp J, Chintha KK, He Z, Brooks JH, Carreiro S, Derefinko KJ. Using wearable technology to detect prescription opioid self-administration. Pain. 2022 Feb 1;163(2):e357-e367. doi: 10.1097/j.pain.0000000000002375.

  PMID: 34270522 DERIVED

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.

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Karen J Derefinko, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: March 13, 2018
• Study Start: August 14, 2017
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)