What side effects are associated with this type of intervention?

Common treatments for opioid addiction include methadone, buprenorphine, and naltrexone. Methadone and buprenorphine, both opioid agonists, can cause side effects such as constipation, sweating, sexual dysfunction, and potential for misuse. Naltrexone, an opioid antagonist, can lead to side effects like nausea, headache, dizziness, and in some cases, liver toxicity. The glutamate modulator being studied for facilitating rapid naltrexone induction may have side effects related to glutamate modulation, such as potential neuropsychiatric effects, but specific side effects are not well-documented and require further research.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of opioid addiction, including methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are long-acting opioids used for maintenance therapy, while naltrexone is an opioid antagonist used for relapse prevention following detoxification. The trial mentioned is studying a glutamate modulator to facilitate rapid non-opioid based naltrexone induction, which is a novel approach compared to traditional opioid-based treatments.

What other types of research exist?

Promising alternatives to glutamate modulators for opioid addiction treatment include: 1) Long-acting injectable naltrexone (XR-NTX), which blocks opioid effects for at least 4 weeks and is indicated for relapse prevention following detoxification. 2) Buprenorphine, a partial opioid agonist that can be administered sublingually or via transdermal patches, offering a safer profile with a ceiling effect on respiratory depression. 3) Sublingual buprenorphine/naloxone combination, which reduces misuse potential and is effective for maintenance therapy. These alternatives provide effective options for opioid addiction treatment with varying mechanisms and administration routes.

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Glutamate Modulator

Rapid Naltrexone Initiation for Opioid Addiction

Phase 3

Waitlist Available

Led By Elias Dakwar, MD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 to 70 years

In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges

Must not have

History of inability to tolerate study medications

For women of childbearing potential: positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 12

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the central nervous system due to glutamate modulation such as headaches, dizziness, or mood changes; gastrointestinal issues; possible liver enzyme elevations; and any known risks associated with naltrexone including nausea and risk of overdose if opioids are used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My overall health is good, as confirmed by recent medical exams and tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had reactions to similar medications in past studies.

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I am not pregnant, breastfeeding, and I am willing to use birth control.

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I am on a buprenorphine treatment or use it regularly.

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I use methadone regularly or am on a methadone maintenance program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiographic imaging procedure

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CI-581aExperimental Treatment1 Intervention

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)

Group II: CI-581bPlacebo Group1 Intervention

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)

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for opioid addiction include medications like methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are opioid agonists that work by binding to the same receptors in the brain as opioids, reducing cravings and withdrawal symptoms without producing the same high, thus helping to stabilize the patient. Naltrexone, an opioid antagonist, blocks the effects of opioids, preventing any high if the patient relapses. The use of glutamate modulators, as studied for facilitating rapid non-opioid based naltrexone induction, highlights the role of glutamate in reducing cravings and withdrawal symptoms, potentially offering a faster and non-opioid based pathway to initiate naltrexone treatment. This is crucial for opioid addiction patients as it provides more options for individualized treatment plans, potentially improving adherence and outcomes.

Glutamate-induced analgesia: blockade and potentiation by naloxone.The novel mGluR2/3 agonist LY379268 attenuates cue-induced reinstatement of heroin seeking.Dissociation between rewarding and psychomotor effects of opiates: differential roles for glutamate receptors within anterior and posterior portions of the ventral tegmental area.