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Auricular Neurostimulation for Opioid Use Disorder (RESTORE Trial)
RESTORE Trial Summary
This trial is testing whether tAN can help prevent relapse better than extended-release injectable naltrexone.
RESTORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESTORE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESTORE Trial Design
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Who is running the clinical trial?
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- I have an ear infection or my ear structure is not typical.I can understand and agree to the study's requirements.I am not willing to switch to medication that blocks opioid effects after detox.I am not pregnant or breastfeeding.I have been using long-acting opioids like methadone or buprenorphine for 5 or more days.I have a history of neurological diseases or traumatic brain injury.I have a serious health or mental condition that is not under control.I am between 18 and 65 years old.
- Group 1: Active tAN + lofexidine
- Group 2: Active tAN + placebo
- Group 3: Sham tAN + placebo
- Group 4: Sham tAN + lofexidine
- Group 5: extended-release injectable naltrexone
- Group 6: Active tAN + extended-release injectable naltrexone
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age range of participants in this experiment inclusive of those over 75?
"This study is looking for volunteers aged 18 and above, but not exceeding 65."
What therapeutic benefits does Naltrexone Injection provide?
"Naltrexone Injection is often prescribed for the long-term management of weight, but can also be employed to stimulate physical activity and regulate pain associated with calorie restriction."
How many participants are involved in this clinical trial?
"Affirmative, clinicaltrials.gov documents indicate that this scientific investigation is actively enrolling participants. The trial was originally posted on May 25th 2022 and saw its most recent update in October 19th 2022; it requires 168 volunteers from 3 distinct sites."
Who is the ideal candidate to join this experimental investigation?
"This medical trial is enrolling 168 participants, aged 18 to 65, that have been diagnosed with opioid use disorder (OUD). To qualify for this study, patients must present a COWS score of 8 or higher and be deemed in mild-to-moderate withdrawal at baseline assessment. Additionally, they should display signs of current dependence on opioids - whether through prescription or illicit means."
Are there still vacancies on this clinical experiment for participants?
"According to records on clinicaltrials.gov, this medical trial is currently enrolling participants; the study was advertised publicly for the first time on May 25th 2022 and underwent its most recent update in October of that same year."
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