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Lemborexant + Naltrexone for Alcoholism
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My liver function tests are not more than 3 times the normal limit.You have a substance use disorder, except for nicotine and cannabis.I have been diagnosed with narcolepsy and may have other stable health conditions or use psychiatric medications.You are admitted to The Menninger clinic.You have a history of alcohol use disorder and meet the criteria for alcohol use disorder as specified in the DSM-5.I have not taken opioid medications in the last 10 days.I am currently taking prescribed benzodiazepines or sleep medications regularly.I am between 18 and 65 years old.I am between 18 and 65 years old.I am allergic to naltrexone or lemborexant.You are currently experiencing symptoms of alcohol withdrawal.I have not taken naltrexone or lemborexant in the last 30 days.You have been diagnosed with insomnia by a doctor using specific criteria outlined in the DSM 5 manual, and the diagnosis has been confirmed with additional tests.You are currently pregnant or breastfeeding.You have been diagnosed with insomnia by a mental health professional using specific criteria from the DSM-5 and confirmed with another assessment tool called SCID-5.
- Group 1: Lemborexant plus Naltrexone
- Group 2: Placebo plus Naltrexone
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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)."
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."
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."
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."
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."
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