Rapid Naltrexone Initiation for Opioid Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help individuals with opioid addiction begin treatment with naltrexone, a medication that blocks opioid effects. Researchers aim to determine if a new drug, CI-581-a or CI-581-b, can facilitate a quicker and more comfortable transition to naltrexone without using other opioids. Participants will receive either the new drug or a placebo (a non-active treatment) during the trial. The trial seeks individuals who have experienced opioid use disorder for at least six months and are interested in naltrexone treatment after detox. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that participants not be on methadone or buprenorphine maintenance treatment, and they must not be taking psychotropic or other medications that might interact with the study medications. If you are on these medications, you may need to stop taking them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
An earlier study tested the treatment called CI-581-a for safety in people. The study found that most participants handled the treatment well. Some experienced mild side effects like headaches and nausea, but these were not serious and didn't last long.
This is encouraging for those considering joining the trial. The current trial's advanced stage indicates some trust in the treatment's safety. More participants have used it without major problems. For concerns about side effects or how the treatment might affect you, consult the trial team. They can provide detailed information based on the latest research.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for opioid addiction, which often involves gradual naltrexone initiation alongside treatments like methadone or buprenorphine, CI-581a offers a rapid initiation approach. Researchers are excited about CI-581a because it is administered during moderate withdrawal, potentially reducing the discomfort and delay associated with traditional methods. This treatment uses a specific dosing regimen (0.11 mg/kg 2-min bolus followed by 1.3 mg/kg over 90 min) that aims to swiftly transition patients to naltrexone, possibly improving adherence and outcomes. Meanwhile, CI-581b serves as a placebo comparator, helping researchers understand the true efficacy of CI-581a.
What evidence suggests that this trial's treatments could be effective for opioid addiction?
Research suggests that CI-581-a, which participants in this trial may receive, might help individuals start using naltrexone more quickly without first using opioids. Naltrexone blocks opioid effects for about four weeks, aiding in relapse prevention after detox. CI-581-a likely affects glutamate, a brain chemical involved in addiction, potentially easing and accelerating the start of naltrexone use. Although more information is still being gathered, this approach aims to alter brain chemistry to reduce withdrawal symptoms, potentially smoothing the transition for those with opioid use disorder.16789
Who Is on the Research Team?
Elias Dakwar, MD
Principal Investigator
NYSPI
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with opioid use disorder for at least six months, confirmed by tests. Participants must be in good health as determined by medical exams and lab tests, not on conflicting medications, and interested in naltrexone treatment. Pregnant or breastfeeding women, those with certain psychiatric disorders or unstable physical conditions like severe hypertension or liver disease are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Detoxification and Washout
Participants undergo nonopioid detoxification and receive CI-581a or CI-581b during the washout phase
Naltrexone Titration
Naltrexone titration schedule is initiated with close monitoring to ensure tolerability
Treatment
Participants receive 12 weeks of mindfulness-based relapse prevention and motivational interviewing sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CI-581-a
- CI-581-b
Trial Overview
The study is testing the effectiveness of two glutamate modulators (CI-581-a and CI-581-b) to quickly start patients on extended-release naltrexone without using opioids. It's a randomized controlled trial where participants receive one of the test drugs to see if it helps prevent relapse after detoxification from opioids.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
CI-581a will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated. (0.11 mg/kg 2-min bolus followed by 1.3 mg/kg over 90 min)
CI-581b will be administered during the washout phase when participants are experiencing moderate withdrawal, as well as the following day when the naltrexone titration is initiated. (2-min saline bolus followed by 0.0125 mg/kg over 90 min)
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York State Psychiatric Institute
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Published Research Related to This Trial
Citations
The opioid use disorder core outcomes set (OUD–COS) for ...
The opioid use disorder core outcomes set (OUD–COS) for treatment research: findings from a Delphi consensus study
Opioid Use Disorder: Evaluation and Management - NCBI - NIH
Cognitive behavioral therapy is most effective if combined with medications; however, there are mixed results on its effectiveness.[12][24].
Rapid Naltrexone Initiation for Opioid Addiction
Trial Overview The study is testing the effectiveness of two glutamate modulators (CI-581-a and CI-581-b) to quickly start patients on extended-release ...
Treatment for Opioid Use Disorder: Population Estimates
The percentage of adults who needed OUD treatment was elevated among those who, during the previous year, had any mental illness (9.0%), used.
Long-term Risk of Overdose or Mental Health Crisis After ...
These findings suggest that opioid tapering was associated with increased rates of overdose, withdrawal, and mental health crisis extending up to 2 years after ...
Psychiatry.org - Opioid Use Disorder
An estimated 3-12% of people treated with opioids for chronic pain will develop an addiction or abuse with negative consequences.(12) Approximately 8.6 million ...
Development of the Revised Opioid Risk Tool to Predict ...
A score of 2 or lower indicates low risk for future opioid use disorder; a score of >/= 3 indicates high risk for opioid use disorder. Mark each box that ...
Pain Management and the Opioid Epidemic - NCBI Bookshelf
With regard to the risks associated with the use of prescription opioids, it has been shown that once patients have been taking opioids longer than 90 days, the ...
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SAMHSA's updated Overdose Prevention and Response Toolkit provides guidance to a wide range of individuals on preventing and responding to an overdose.
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