Daridorexant for People With Insomnia and Alcohol Use Disorder Study

Официальное название

Daridorexant for the Treatment of Sleep Amongst Those With Alcohol Use Disorder Using the Addiction Neuroclinical Assessment Framework

Обзор

The goal of this clinical trial is to see if a sleep medication, daridorexant (DTX), can help decrease drinking in people who have alcohol use disorder (AUD) and insomnia. The main questions it aims to answer are: * Can DTX decrease alcohol use in individuals with insomnia better than placebo? * Can DTX increase sleep time and other sleep related outcomes better than placebo? Participants will: * Take prescribed medication (DTX or Placebo based on which group they are randomized to). * Provide urine, breath, saliva, and blood samples. * Come in for bi-weekly (once every 2 weeks) in-person visits. * Answer questionnaires and surveys related to sleep, substance use, and physical/mental health. * Use an EEG headband to track brain activity at night. * Come in for 3 follow up visits one month, six months, and one year after treatment.

Подробное описание

Double-blind placebo controlled study focusing on the ability of an already FDA approved medication for sleep disorders on AUD that will rigorously measure alcohol use, medication adherence, and sleep outcomes.

Participants will come in for a baseline appointment that consists of informed consent and baseline data collection including blood, saliva, breath, and urine samples, as well as a brief medical history to determine safety in this study.

Once approved for treatment, participants will be randomized into one of two arms, placebo + standard treatment or DTX + standard treatment. Both arms will include urine, breath, device data (from the EEG headband and medication adherence bottle cap) and self-report data. The only difference in arms will be whether the participant is taking active treatment or placebo medication. Participants can earn rewards using contingency management for adhering to medication protocols, which are objectively verified using the Medication Event Monitoring System (MEMS) cap.

Once the participant has completed all 12 weeks of treatment, they are then moved into the follow-up phase, where they will have 3 more in-person visits at 1-month, 6-month, and 1-year post treatment.

Вмешательства

• Препарат Daridorexant
  Daridorexant 50mg (2 25mg tablets) taken once daily at night for the 12 week treatment phase.
• Препарат Placebo
  Placebo medication used as comparator for active treatment (DTX). Will be distributed as 2 25mg tablets taken once daily at night similar to the active treatment medication
• Поведенческое Brief Counseling
  All participants, regardless of group assignment will receive an equivalent dose of brief, manualized counseling made available by NIAAA called Take Control at equivalent intervals during the treatment period. Counseling will require 15 minutes every other week (6 sessions total across the 12-week treatment plan) and will include reminders about the importance of medication adherence.
• Устройство MEMS and Medication Accounting
  All participants will receive the Medication Event Monitoring System (MEMS) bottle cap device at their first treatment period visit and receive a brief, 10-minute introduction on how to use the device. All participants will be instructed to take prescribed medication. At each subsequent visits, research staff will use a calendar to review the study medications taken since last visit using a timeline followback (TLFB) approach, verified electronically with the MEMS device providing medication adh
• Поведенческое Contingency Management for Medication Adherence
  During the treatment period, each participant will receive electronic gift cards in exchange for demonstrating 85% adherence to prescribed medication over the past 14 days of remote observation. Adherence data will be available through the MEMS device portal.

Первичные конечные точки

• Self-Reported Drinks Per Day and Heavy Drinking Days [Срок оценки: From enrollment to end of treatment at 12 weeks, and follow-up at 1-month, 6-months, and 1-year post treatment.]
• Biochemically Verified Alcohol Use and Heavy Drinking Days [Срок оценки: From enrollment to end of treatment at 12 weeks, and follow-up at 1-month, 6-months, and 1-year post treatment.]

Вторичные конечные точки (2)

• Total Sleep Time [Срок оценки: From enrollment through end of treatment at week 12 and follow-up at the 1-month, 6-months, and 1-year post treatment.]
• Self-Reported Quality of Sleep and Daytime Function [Срок оценки: From enrollment through end of treatment at week 12, and follow-up at the 1-month, 6-months, and 1-year post treatment.]

Критерии участия

Критерии включения

• DSM-5 diagnosis of an insomnia disorder (i.e., difficulty initiating/maintaining sleep, early morning awakening equal or greater than 3 nights a week for equal or greater than 3 months, daytime impairment, and exclusion of other causes)
• Insomnia Severity Index (ISI) score equal or greater to 15 indicating the presence of moderate or severe insomnia
• 4 or more standard drinks on 4 or more occasions in the past 30 days
• Seeking insomnia and AUD treatment
• Aged 18+ years
• DSM-5 diagnosis of AUD
• Ability to read and speak English
• Breath Alcohol of 0.00 for informed consent
• Ability to provide written informed consent
• Non-lactating women of childbearing age using a reliable form of birth control with a negative serum pregnancy test at baseline

Критерии исключения

• Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
• Receipt of any pharmacotherapy for sleep or AUD in the past 30 days
• Current DSM-5 diagnosis of sever substance use disorder that is not currently being treated, other than nicotine
• Suicide attempt in the last 2 years
• Moderate hepatic impairment indicating an inability to receive the full dose of 50mg/day
• History of narcolepsy or complex sleep behaviors with sedative-hypnotics
• Any other medical (discernible by initial blood test) or psychiatric condition that our medical team determines would compromise safe participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• WSU Research Clinic — Spokane

Идентификаторы

NCT: NCT07701928 · 26-0375

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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