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Buprenorphine + XR-Naltrexone for Opioid Use Disorder (COMBO Trial)
COMBO Trial Summary
This trial will compare the effectiveness of a new drug combination to treating opioid addiction with extended release naltrexone alone. It is a double-blind, placebo-controlled study, meaning neither the participants nor the researchers will know who is receiving the new treatment or the placebo. The study will last 24 weeks, during which participants will receive six injections of either the new treatment or a placebo. The study's goal is to see if the new treatment can improve treatment retention, reduce opioid craving, and improve mood.
COMBO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMBO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 4 trial • 1269 Patients • NCT00315341COMBO Trial Design
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Who is running the clinical trial?
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- I have completed detox and received an XR-NTX shot within the last 2 weeks.I am over 60 and may have early cognitive decline, as shown by my MMSE score.I do not have a severe addiction to alcohol or sedatives that would complicate medical detox.I have been diagnosed with opioid addiction for at least 6 months.My overall health is good, as confirmed by recent medical exams and tests.I have used opioids within the last 30 days.I have been diagnosed with opioid addiction for at least 6 months.I use no more than 8 mg of buprenorphine up to 3 days a week, and haven't used it since starting XR-NTX.I received my first XR-NTX injection more than 2 weeks ago.My overall health is good, with no significant issues found in recent medical tests.I am seeking treatment for opioid addiction and open to using XR-NTX.I am between 18 and 65 years old and interested in relapse prevention treatment.I am allergic to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.You are actively seeking treatment for addiction to opioids.I need opioids for a painful condition or upcoming surgery.I have not used methadone in the week before starting XR-NTX.I do not have a severe illness like advanced heart or liver disease.I am currently using opioids or have recently completed detox and started on XR-NTX.
- Group 1: Placebo
- Group 2: Buprenorphine-naloxone
- 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
How many volunteers are needed for this research project?
"That is correct, the trial indicated on clinicaltrials.gov is looking for new patients to enroll. The date range listed shows that this study was posted on 8/1/2022 and last updated on 8/11/2022. They are seeking a total of 180 participants from 1 site."
Is this clinical trial open to people who are not yet 40 years old?
"This clinical trial is only eligible for people aged 18 to 65. Out of the 1,341 total trials, 344 are for individuals below 18 years old and 997 are for senior citizens."
Who would be an eligible candidate for this clinical research?
"The prerequisites for participants of this clinical trial include active opioid use disorder and being between 18-65 years old. Currently, the team is looking to enroll 180 individuals."
Are there any open slots in this research project for new participants?
"The clinicaltrials.gov website confirms that this study is open for recruitment. This trial was first announced on August 1st, 2022 and the most recent update was on August 11th, 2022. Currently, 180 people are needed to take part in this study at a single location."
What is Buprenorphine/naloxone's most popular therapeutic application?
"Buprenorphine/naloxone is used as an intervention for opioids most frequently, but it has also been taken to manage pruritus, pain, and septic shock."
Could you please provide some context for this Buprenorphine/naloxone clinical trial in relation to others like it?
"Currently, there are 60 ongoing studies investigating the efficacy of buprenorphine/naloxone. Of those active studies, 14 are in Phase 3. The majority of clinical trials for this medication are taking place in White River Junction, Vermont; however, 243 different locations across the globe are running trials for this treatment."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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