Withdrawal Symptoms study: [F-18]Fallypride
Official title Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3
ClinicalTrials.gov ID: NCT05834478
What this study is testing
What is [F-18]Fallypride?
This is an investigational radioactive material being studied to help researchers understand opioid withdrawal symptoms. is designed to attach to specific receptors in the brain so that a PET scan can create images of how the brain is working during withdrawal.
Also referred to as Radiolabeled material.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out how different doses of vagus nerve stimulation affect withdrawal symptoms in people with a history of opioid use disorder.
- Who it's for
- The study is looking for adults with a history of opioid use disorder who are experiencing withdrawal symptoms.
- What's involved
- Participants will stay in a research hospital for one week, where they will receive nerve stimulation, have an MRI brain scan, complete questionnaires, and undergo physical monitoring.
- Time commitment
- The study involves a one-week hospital stay and a follow-up phone call 1 to 3 months later.
- Phase 3: a large, late-stage study
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 75
You may be able to join if
- Meet criteria for OUDs based on the DSM5 criteria
- Willing to undergo supervised withdrawal
- Willing to be transitioned to a MOUD or behavioral management during treatment aftercare
You likely can't join if
- Positive pregnancy test or breastfeeding for women
- History of meningitis
- Traumatic brain injury
- Current treatment with methadone, naltrexone, or Suboxone or medications that would be contraindicated with hydromorphone or clonidine administration
- History of head trauma resulting in loss of consciousness (LOC) of greater than one minute where the LOC is not judged to be primarily related to...
- Past year moderate to severe non-opioid use disorders that would require separate withdrawal management
See the full eligibility criteria
- Meet criteria for OUDs based on the DSM5 criteria
- Willing to undergo supervised withdrawal
- Willing to be transitioned to a MOUD or behavioral management during treatment aftercare
- Positive pregnancy test or breastfeeding for women
- History of meningitis
- Traumatic brain injury
- Current treatment with methadone, naltrexone, or Suboxone or medications that would be contraindicated with hydromorphone or clonidine administration
- History of head trauma resulting in loss of consciousness (LOC) of greater than one minute where the LOC is not judged to be primarily related to overdose in the judgment of the study physician
- Past year moderate to severe non-opioid use disorders that would require separate withdrawal management
- Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia
- History of serious medical or neurological illness or organic mental disorder, including liver disease, but also including cardiovascular, gastrointestinal, hepatic, renal, neurologic, or other systemic illness...
- Lack of venous access that would preclude PET imaging
- Active implantable device (i.e. pacemaker) or other VNS device exclusion
- History of shrapnel or other foreign bodies that would preclude MRI scanning
- Positive test for COVID-19
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, 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.