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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after randomization
Awards & highlights

Study Summary

This trial is testing whether adding lemborexant to naltrexone helps reduce alcohol cravings and improve sleep in people with both alcohol use disorder and insomnia.

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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 65 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cue-induced Alcohol Cravings using the Alcohol Urge Questionnaire
Non-Cued Alcohol Cravings using the Penn Alcohol Craving Scale
Secondary outcome measures
Actigraphy to measure Total Sleep Time
Actigraphy to measure sleep efficiency
Actigraphy to measure sleep latency
+7 more

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

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,003 Previous Clinical Trials
6,003,062 Total Patients Enrolled
4 Trials studying Alcoholism
31 Patients Enrolled for Alcoholism

Media Library

Naltrexone (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05458609 — Phase 3
Alcoholism Research Study Groups: Lemborexant plus Naltrexone, Placebo plus Naltrexone
Alcoholism Clinical Trial 2023: Naltrexone Highlights & Side Effects. Trial Name: NCT05458609 — Phase 3
Naltrexone (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05458609 — Phase 3
~4 spots leftby Jun 2025
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