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Injectable Buprenorphine vs Naltrexone for Opioid Use Disorder
Study Summary
This trial will investigate how treatments for opioid use disorder affect brain activity. It will use up to three monthly injections of buprenorphine and naltrexone and measure brain activity with MRI scans.
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 have a psychiatric condition but only take medication for mild to moderate depression, anxiety, or ADHD without stimulants.I am prescribed opioids as my main pain medication.I am of childbearing age and do not use birth control.I am open to trying long-lasting injectable treatments.My main substance use is not opioids.I have never been diagnosed with a psychotic disorder like schizophrenia or bipolar type 1.I do not have conditions like active liver disease that would make the study medications unsafe for me.I have a condition that might interfere with pain medication.I have a stable address, speak English well, and have access to a phone.I am between 18 and 65 years old.
- Group 1: Buprenorphine
- Group 2: Naltrexone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the FDA given its stamp of approval to Buprenorphine?
"Our team assigned buprenorphine a score of 2, as we have some confidence in its safety from Phase 2 trials but no evidence yet on the drug's efficacy."
What goals does this investigation seek to achieve?
"During this Phase 2 (Years 3-6) study, researchers will evaluate the Fronto-limbic brain fMRI response to XRNTX and XRBUP. Secondary metrics include medication adherence, opioid craving as measured by a standard clinical questionnaire (OCS), and self-reported opioid withdrawal assessed using a Likert scale on the Subjective Opioid Withdrawal Scale (SOWS)."
For which demographic is this study most suitable?
"This medical study seeks 60 participants, aged 18-65, who have been medically diagnosed with opioid use disorder (OUD). Candidates must also demonstrate that opioids are their primary drug of choice; be interested in extended release agonist or antagonist treatment; possess a stable address and working command of the English language; as well as access to telephone services."
Are participants aged 80 or above eligible for inclusion in this investigation?
"Eligibility for this study is limited to those between legal adulthood and seniority, i.e., individuals aged 18-65."
Are researchers currently enrolling participants in this experiment?
"As found on clinicaltrials.gov, this particular medical experiment is not accepting new participants at present. It was initially made public on November 1st 2022 and lastly updated October 24th 2022. Despite the fact that it isn't recruiting patients right now, there are 533 other trials available which are presently seeking volunteers."
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