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CI-581-a for Opioid Addiction
Study Summary
This trial is testing if a glutamate modulator can help with a rapid non-opioid based naltrexone induction, to help prevent opioid use disorders.
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 not on medications that could react badly with the study drugs.I am interested in taking extended-release naltrexone for maintenance.I do not have uncontrolled high blood pressure, severe anemia, active liver disease, or untreated diabetes.I am between 18 and 70 years old.My overall health is good, as confirmed by recent medical exams and tests.I have chronic pain that might need opioids or surgery.I have had reactions to similar medications in past studies.I am not pregnant, breastfeeding, and I am willing to use birth control.I am on a buprenorphine treatment or use it regularly.I use methadone regularly or am on a methadone maintenance program.
- Group 1: CI-581a
- Group 2: CI-581b
- 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
For whom is this medical experiment accessible?
"This research is looking for a cohort of 100 adults aged 18-70 with opioid dependence. In order to be eligible, one must meet the age criteria and any other requirements specified by the study."
How many participants are included in this clinical examination?
"Affirmative. Information found on clinicaltrials.gov states that this trial is actively recruiting participants, with the initial listing date being November 25th 2017 and the most recent update occurring on November 30th 2022. The investigation requires 100 patients to be enrolled from 1 site."
What have been the reported effects of CI-581-a on individuals?
"CI-581-a has been assessed to be of the highest safety standard, scoring a 3 on our team's rating system. This is due to its Phase 3 trial status and abundance of previously collected data which demonstrate efficacy as well as safety."
Are the enrolment criteria for this trial inclusive of individuals aged forty or older?
"As per the specified guidelines, individuals must be between 18 and 70 years old in order to take part in this clinical trial."
Is enrollment still available for participants in this research endeavor?
"Affirmative. The clinical trial registry on clinicaltrials.gov confirms that this research project, which had its inception on November 25th 2017, is actively searching for participants. A total of 100 individuals are needed to be recruited across a single location."
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