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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
Age 18-65 years
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
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I am between 18 and 65 years old.
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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
997 Previous Clinical Trials
6,002,011 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are researchers hoping to find at the conclusion of this trial?

"The primary outcome of this clinical trial will be Non-Cued Alcohol Cravings as measured by the Penn Alcohol Craving Scale, and will be evaluated approximately 4 weeks after Randomization. Secondary outcomes that will also be assessed include Suicide Risk Using the Suicide Behavior Questionnaire-Revised (SBQ-R), Sleep Quality Using the Pittsburgh sleep quality index (PSQI), and Depression using the Patient Health Questionnaire (PHQ-9)."

Answered by AI

Are there any barriers to participating in this experiment?

"To qualify for this trial, participants must be within the ages of 18-65 and have a diagnosis of alcoholism. Currently, 14 people have been accepted into the study."

Answered by AI

Are people above the age of 40 able to participate in this clinical trial?

"This study's participants must fall between 18 and 65 years old. If an applicant does not meet this criterion, there are 21 other trials for minors and 204 for seniors that they may be suited for."

Answered by AI

Are researchers actively working to add more participants for this trial?

"No, this specific clinical trial is not recruiting patients at the moment. Although, it is worth noting that there are 273 other clinical trials with open enrolment presently. The original posting date for this study was 8/6/2022 and the most recent update to the listing was on 8/11/2022."

Answered by AI

Has the FDA accepted Lemborexant in combination with Naltrexone?

"The safety of taking Lemborexant plus Naltrexone has been backed by multiple rounds of clinical data, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The Menninger Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Recent research and studies
~4 spots leftby Mar 2025