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XR-Buprenorphine Initiation Strategies for Opioid Use Disorder in Jail
Study Summary
This trial will compare two approaches for starting buprenorphine treatment for opioid use disorder among jail inmates. Inmates will either start treatment at the time of admission or shortly before release. Researchers will compare how likely inmates are to participate in treatment, levels of in-jail opioid use, continuation of pharmacotherapy and other OUD treatment in the community, and levels of opioid use 4 and 12 weeks following discharge.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am incarcerated but can sign a consent form in English.I was on methadone or buprenorphine before jail and plan to continue after.I do not have severe health or mental health issues that would make participating dangerous.I need opioids to manage my chronic pain.You currently have a serious problem with using opioid drugs, as diagnosed by a specific set of guidelines.I am allergic or have a bad reaction to certain medications.
- Group 1: XR-B Induction at Pre-Release
- Group 2: XR-B Induction at Admission
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 there an opportunity for me to take part in this clinical investigation?
"This study seeks 180 subjects with a diagnosis of opioid abuse disorder between the ages 18 and 65. In order to qualify, they must be incarcerated, able to sign informed consent in English, have an expected release date within 3-7 months, exhibit reasonable prospects for completing 3+ months of post-release treatment, agree to randomly assigned timing for XR-B medication intake upon jail entry or shortly after release date, and demonstrate signs of moderate-to-severe OUD (DSM 5)."
Are any new participants being sought for this clinical trial?
"Per clinicaltrials.gov, enrollment for this trial has been suspended since August 17th, 2022 when the post was last updated after being initially published on November 1st of the same year. Nevertheless, 291 other trials are still scouting for participants currently."
Does eligibility for this trial encompass participants under the age of 65?
"This medical trial has a limited age range, namely 18-65. However, there are other studies available for those outside this window - 22 trials open to minors and 240 open to seniors."
What are the goals of this clinical evaluation?
"The primary outcome of this study will be monitored for up to 10 months, and it is the number of participants who receive the first dose of XR-B during incarceration. Secondary metrics include: a percentage breakdown that evaluates opioid use at 3 months post-release based on composite urine toxicology results and self-reported drug use through TLFB; an analogous measure taken 1 month after release; and finally, total days of opioid utilization reported by patients in TLFB surveys 3 months post-release."
What potential risks can be associated with Extended-Release Buprenorphine Injection?
"Due to its Phase 4 designation, Extended-Release Buprenorphine Injection was assigned a security rating of 3 out of 3. This represents the highest level of safety given that it has been approved for medical use."
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