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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

Tracking Information
First Submitted Date October 24, 2017
First Posted Date March 13, 2018
Last Update Posted Date October 11, 2018
Actual Study Start Date August 14, 2017
Actual Primary Completion Date October 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 5, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Opioid Physiology Project
Official Title Opioid Physiology Project
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).
Detailed Description

Opioid overdose is a leading cause of accidental death in the USA, with death rates rising steadily over the last 20 years (CDC, 2015). Of the over 22,000 deaths relating to pharmaceutical overdose in 2011, three quarters involved opioid analgesics (Fletcher et al., 2011). Increases in problematic opioid use have paralleled a corresponding increase in drug treatment admissions (DOHH, 2014). Drug treatment programs currently focus on behavioral and pharmacologic interventions to sustain abstinence, and success is typically measured by self-reports or urine drug screening (NIDA, 2016). Both measurement methods are limited by such factors as recall bias, distortion, and lack of precision (Fishman et al., 2000). A detection method that accurately detects opioid use as it occurs in real time would provide several distinct advantages, including the ability to obtain environmental and behavioral contexts surrounding relapse as well as an opportunity for targeted interventions.

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).

Participants who are enrolled will complete baseline questionnaires regarding psychological and behavioral risks of substance use. Next, participants will be asked to wear the wristband sensor for 1 day prior to surgery, and up to 30 days post-surgery, or as long as opioid medication is prescribed. Physiological measurement will be conducted via the Empatica E4 wristband biosensor, which measures electrodermal activity, skin temperature, and locomotion data. Opioid use will detected through biosensor activity. Participants will be recruited over a 6 month period, in cohorts of 10. All study procedures will be approved by the UTHSC IRB.

Hilbert transform analyses combined with paired t-tests will be used to compare the biosensor data: (A) within subjects, before and after administration of opioids; and (B) between subjects, controlling for hand dominance, gender, and length of prescription.

Results of analyses will be shared with the College of Dentistry, and will subsequently be disseminated through a peer-reviewed publication.

Role of the College of Dentistry:

  • To refer patients to Karen Derefinko's study team for possible recruitment into the study prior to the scheduled surgery.
  • If possible, to allow a research coordinator to consent and interview participants on site in an available private room.
  • To provide prescription data (type, dose, and duration) to study team, with signed participant consent.

Epigenetics:

Environmental exposures including prescription drugs and drugs of abuse can have a pronounce effect on the epigenome (Nestler, 2014; Nielsen et al., 2012). There is growing evidence that use of opioids results in changes in DNA methylation, an important epigenetic modification that can alter gene expression. Such changes may play a mechanistic role in forming an "epigenetic memory" of drug exposure and development of dependence (Doehring et al., 2013; Tuesta & Zhang, 2014). For this study, the coordinator will collect buccal swabs (cheek epithelial cells) from study subjects at the start of study and at follow up visits. Buccal cells will be collected non-invasively using the DNA Genotek 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 evaluate the longitudinal change in the methylome that may be induced by short-term opioid use.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition
  • Tolerance
  • Withdrawal
  • Addiction
  • Epigenetic Changes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2018)
87
Original Estimated Enrollment
 (submitted: March 5, 2018)
80
Actual Study Completion Date October 5, 2018
Actual Primary Completion Date October 5, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03462797
Other Study ID Numbers 17-05380-XP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Tennessee
Study Sponsor University of Tennessee
Collaborators Not Provided
Investigators
Principal Investigator: Karen J Derefinko, PhD University of Tennessee Health Science Center
PRS Account University of Tennessee
Verification Date October 2018