Clinical trial for Opioid Withdrawal
Official title Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain
ClinicalTrials.gov ID: NCT05555485
What this study is testing
- What it's testing
- This study is testing whether a gentle ear stimulation device can change pain and withdrawal symptoms.
- Who it's for
- You may be able to join if you have chronic pain and are going through opioid withdrawal.
- What's involved
- You will stay at the research center for four days. You will receive either real or pretend ear stimulation for two days, four hours each day, and you will fill out questionnaires, do sensory tests, and have a brain MRI.
- Time commitment
- The study lasts about four days with daily visits while you stay at the center.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Males and females between 18 and 65 years of age
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
- Presence of pain on more than half of the days in the last six months
- Must have proof of prescribed medication by either showing a prescription bottle with the individual's name or the presence of a prescription on the...
- Willingness to taper opioid dose by at least 10%
You likely can't join if
- Currently receiving treatment for cancer
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participant has abnormal ear anatomy or current ear infection present
- Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
- Currently receiving a prescription benzodiazepine medication
See the full eligibility criteria
- Males and females between 18 and 65 years of age
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
- Presence of pain on more than half of the days in the last six months
- Must have proof of prescribed medication by either showing a prescription bottle with the individual's name or the presence of a prescription on the Prescription Drug Monitoring Program (PDMP)
- Willingness to taper opioid dose by at least 10%
- Patient or provider requests opioid dose reduction or discontinuation.
- Urine Drug Screen (UDS) must be positive for their prescribed opioid
- Urine Drug Test must be negative for illicit drugs, benzodiazepines, and nonprescribed opioids
- Must agree to use nicotine patches and/or gum instead of smoking or vaping in the UTMB facilities
- Currently receiving treatment for cancer
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participant has abnormal ear anatomy or current ear infection present
- Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
- Currently receiving a prescription benzodiazepine medication
- Current prescription opioid dose \>50 MME/day
- Current abuse of illicit drugs or alcohol (nicotine use is acceptable).
- Surgery within the previous month
- Report of suicide attempt or psychiatric hospitalization in the past 10 years.
- Current suicidal ideation with specific plan or intent
- Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
- Females who are pregnant or lactating
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the...
The study team makes the final eligibility decision.
Where it is enrolling
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Galveston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.