What side effects are associated with this type of intervention?

Naltrexone, an opioid receptor antagonist, is commonly used to treat alcoholism and can cause side effects such as nausea, headache, dizziness, fatigue, and liver toxicity. Lemborexant, a dual orexin receptor antagonist, is primarily used for insomnia and may cause side effects like drowsiness, headache, and abnormal dreams. Combining these treatments may require careful monitoring for additive side effects such as increased sedation and potential liver issues.

What prior FDA approvals exist?

Naltrexone, an opioid receptor antagonist, has been FDA-approved for the treatment of alcohol dependence. It works by reducing the rewarding effects of alcohol, thereby decreasing the urge to drink. Another FDA-approved medication for alcoholism is acamprosate, which helps to stabilize chemical signaling in the brain that would otherwise be disrupted by alcohol withdrawal. Disulfiram is also approved and works by causing unpleasant effects when alcohol is consumed. While lemborexant, a dual orexin receptor antagonist, is being studied for its potential benefits in treating insomnia and alcohol cravings, it has not yet been approved for the treatment of alcoholism.

What other types of research exist?

Promising novel alternatives to Naltrexone plus Lemborexant for treating alcoholism in 2024 include: 1) Baclofen, a GABA-B receptor agonist, which has shown potential in reducing alcohol cravings and consumption. 2) Gabapentin, which modulates GABA activity and has been effective in reducing alcohol dependence and withdrawal symptoms. 3) Varenicline, a partial agonist at nicotinic acetylcholine receptors, which has shown promise in reducing alcohol consumption. 4) Nalmefene, an opioid receptor modulator, which has been effective in reducing heavy drinking days. These alternatives offer different mechanisms of action and have shown efficacy in clinical trials.

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Lemborexant + Naltrexone for Alcoholism

Phase 3

Waitlist Available

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Age 18-65 years

Be older than 18 years old

Must not have

unstable medical conditions (e.g. liver enzymes (ALT and AST) more than 3 times normal)

Use of any opioid medication within the past 10 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after randomization

Awards & highlights

Pivotal Trial

Summary

This trial tests a combination of naltrexone, which reduces alcohol cravings, and lemborexant, a sleep aid, in people with alcohol use disorder and insomnia. The goal is to see if this combination can better manage both alcohol cravings and sleep problems compared to using naltrexone alone. Improving sleep may help reduce the risk of relapse in these patients. Naltrexone has been widely studied and shown to reduce alcohol cravings and intake in alcohol-dependent individuals.

Who is the study for?

This trial is for adults aged 18-65 with alcohol use disorder and insomnia, as diagnosed by DSM-5 criteria. Participants must not have used opioids or certain sedatives recently, be free from acute alcohol withdrawal, and cannot have liver issues or other drug disorders (except nicotine/cannabis). Pregnant/breastfeeding individuals or those with a known sensitivity to the study drugs are excluded.

What is being tested?

The study aims to see if adding Lemborexant to Naltrexone helps reduce alcohol cravings more than just Naltrexone alone in people with both alcoholism and sleep problems. It also looks at how this combination affects sleep quality, mood, and thoughts of self-harm.

What are the potential side effects?

Possible side effects include daytime drowsiness, headache, unusual dreams or nightmares related to Lemborexant; while Naltrexone may cause nausea, headaches, dizziness, anxiety or restlessness.

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 65 years old.

Exclusion Criteria

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

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My liver function tests are not more than 3 times the normal limit.

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I have not taken opioid medications in the last 10 days.

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I am currently taking prescribed benzodiazepines or sleep medications regularly.

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I am allergic to naltrexone or lemborexant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cue-induced Alcohol Cravings using the Alcohol Urge Questionnaire

Non-Cued Alcohol Cravings using the Penn Alcohol Craving Scale

Secondary study objectives

Actigraphy to measure Total Sleep Time

Actigraphy to measure sleep efficiency

Actigraphy to measure sleep latency

+7 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Lemborexant plus NaltrexoneActive Control2 Interventions

10 milligrams of Lemborexant will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for a total of 4 weeks

Group II: Placebo plus NaltrexonePlacebo Group1 Intervention

10 milligrams of placebo will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for a total of 4 weeks

0 / 5Eligibility 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

Naltrexone, an opioid receptor antagonist, blocks the euphoric and sedative effects of alcohol, reducing cravings and the risk of relapse. Lemborexant, a dual orexin receptor antagonist, is used to treat insomnia and may improve sleep quality in alcohol use disorder patients. These mechanisms are important as they help manage cravings and improve sleep, both of which are critical for successful recovery in alcoholism patients.