100 Participants Needed

Rapid Naltrexone Initiation for Opioid Addiction

KO
ED
Overseen ByElias Dakwar, MD
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a long-lasting injection to block opioid effects and another medication to ease withdrawal. It targets people with opioid addiction who have finished detox and are at risk of relapse. The treatment prevents opioids from affecting the brain and reduces withdrawal symptoms.

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 naltrexone safe for human use?

Naltrexone has been studied for over three decades and is generally considered safe for human use, with minimal side effects like nausea and abdominal pain in some patients. However, high doses can cause liver damage, and there is a risk of opioid overdose if someone tries to overcome its effects by taking more opioids.12345

How does the drug CI-581-a, CI-581-b differ from other treatments for opioid addiction?

The treatment involves rapid initiation of naltrexone, which is unique because it uses an extended-release injection form that only needs to be administered monthly, improving adherence compared to daily oral naltrexone. This approach is particularly beneficial for patients who struggle with daily medication compliance, offering a more consistent and effective way to manage opioid addiction.16789

What data supports the effectiveness of the drug CI-581-a, CI-581-b for opioid addiction?

Naltrexone, a component of the treatment, is an opioid antagonist that has been shown to help reduce cravings and prevent relapse in opioid addiction when used in an extended-release form, which improves adherence compared to the oral form.19101112

Who Is on the Research Team?

ED

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

DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids or a positive naloxone challenge test
Able to give written informed consent to participate in the study
I am interested in taking extended-release naltrexone for maintenance.
See 1 more

Exclusion Criteria

I am not on medications that could react badly with the study drugs.
History of a use disorder with the study medications
I do not have uncontrolled high blood pressure, severe anemia, active liver disease, or untreated diabetes.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Detoxification and Washout

Participants undergo nonopioid detoxification and receive CI-581a or CI-581b during the washout phase

1 week
Inpatient treatment for up to 5 days

Naltrexone Titration

Naltrexone titration schedule is initiated with close monitoring to ensure tolerability

1 week
Inpatient treatment for up to 5 days

Treatment

Participants receive 12 weeks of mindfulness-based relapse prevention and motivational interviewing sessions

12 weeks
Twice weekly meetings with staff

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CI-581aExperimental Treatment1 Intervention
Group II: CI-581bPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials
481
Recruited
154,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

Naltrexone, an effective treatment for reducing alcohol cravings in individuals with alcohol use disorder (AUD), is significantly underutilized despite its proven safety and efficacy.
A quality improvement project aimed to enhance knowledge and prescribing practices for naltrexone, with goals to increase prescriptions for patients with AUD by 5% and achieve 50% staff participation in educational activities, indicating a proactive approach to improve treatment accessibility.
Education Intervention to Increase Naltrexone Use Among Adult Inpatients With Alcohol Use Disorder.Ipsarides, J.[2023]
The FDA-approved extended-release formulation of naltrexone, administered as a monthly injection, may improve adherence and retention rates in treating opioid dependence compared to the oral form, which has low compliance (less than 30%).
While naltrexone effectively reduces the rewarding effects of opioids to prevent relapse, there are safety concerns, including potential liver damage at high doses and risks of opioid overdose if individuals attempt to overcome the drug's antagonistic effects.
Naltrexone extended-release injection: an option for the management of opioid abuse.Taylor, R., Raffa, RB., Pergolizzi, JV.[2021]
In a 48-week study involving 200 participants with opioid addiction and HIV, the naltrexone implant group showed a significant improvement in maintaining viral loads below 400 copies per mL at 48 weeks compared to the oral naltrexone group, suggesting that long-acting naltrexone may enhance HIV treatment outcomes.
Despite some serious adverse events, including deaths in both groups, the study indicates that longer opioid blockade from the implant may help protect against missed antiretroviral therapy doses and impulsive behaviors that could lead to relapse.
Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial.Krupitsky, E., Blokhina, E., Zvartau, E., et al.[2020]

Citations

Education Intervention to Increase Naltrexone Use Among Adult Inpatients With Alcohol Use Disorder. [2023]
Naltrexone extended-release injection: an option for the management of opioid abuse. [2021]
The use of naltrexone in pathological and problem gambling: A UK case series. [2020]
Naltrexone: its clinical utility. [2013]
Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial. [2020]
Treatment of heroin-dependent persons with antagonists: current status. [2013]
The safety profile of naltrexone in the treatment of alcoholism. Results from a multicenter usage study. The Naltrexone Usage Study Group. [2019]
Naltrexone in addicted business executives and physicians. [2013]
Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
A Randomized Trial Comparing Extended-Release Injectable Suspension and Oral Naltrexone, Both Combined With Behavioral Therapy, for the Treatment of Opioid Use Disorder. [2022]
Baseline characteristics of patients predicting suitability for rapid naltrexone induction. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Case report: Increasing the frequency of intramuscular naltrexone administration in a high risk patient with opioid use disorder. [2022]
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