Addiction Clinical Trial
— OPPOfficial title:
Opioid Physiology Project
NCT number | NCT03462797 |
Other study ID # | 17-05380-XP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 14, 2017 |
Est. completion date | October 5, 2018 |
Verified date | October 2018 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 87 |
Est. completion date | October 5, 2018 |
Est. primary completion date | October 5, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Tennessee College of Dentistry | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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: Physical activity through an accelerometer measuring movement on x,y, and z axes. Heart rate measured in beats per minute (BMP) Skin conductance measured in µs (microseconds) Temperature measured in Celsius (°C) 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 | DNA Methlyation changes | 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 ß-values, which are the ratio of (DNA methylation)/(DNA methylation + DNA unmethylation). We will use DNA Genotek's Oragene Discover for saliva collection. | 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. |
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