Daridorexant for People With Insomnia and Alcohol Use Disorder Study

NCT07701928 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 26-0375
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder; Insomnia

Keywords

Alcohol Use Disorder; AUD; Contingency Management; Insomnia

Outcome Measures

Primary Outcomes (2)

• Self-Reported Drinks Per Day and Heavy Drinking Days

  Self-reported drinks per day using the Timeline Follow-Back (TLFB). Heavy drinking days will be determined if a participant had 4 drinks if assigned female at birth, and 5 drinks if assigned male at birth on any given day.

  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

  Alcohol use will be determined by evaluating ethyl glucuronide (EtG) content in participants urine analysis sample. Heavy drinking days will be determined by an EtG-I cutoff of 100 ng/mL, which is most likely to detect heavy drinking for up to five days and any drinking during the previous two days.

  From enrollment to end of treatment at 12 weeks, and follow-up at 1-month, 6-months, and 1-year post treatment.

Secondary Outcomes (2)

• Total Sleep Time

  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

  From enrollment through end of treatment at week 12, and follow-up at the 1-month, 6-months, and 1-year post treatment.

Other Outcomes (2)

• Addiction Neuroclinical Assessment-Based Moderators of Total Sleep Time

  Enrollment through end of treatment at week 12 and follow-up at the 1-month, 6-month, and 1-year post treatment.

• Addiction Neuroclinical Assessment-Based Moderators of Alcohol Use

  From enrollment through end of treatment at week 12 and follow-up at the 1-month, 6-months, and 1-year post treatment.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Behavioral: Brief Counseling; Device: MEMS and Medication Accounting; Behavioral: Contingency Management for Medication Adherence

Daridorexant

EXPERIMENTAL

Drug: Daridorexant; Behavioral: Brief Counseling; Device: MEMS and Medication Accounting; Behavioral: Contingency Management for Medication Adherence

Interventions

Daridorexant DRUG

Daridorexant 50mg (2 25mg tablets) taken once daily at night for the 12 week treatment phase.

Daridorexant

Placebo DRUG

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

Placebo

Brief Counseling BEHAVIORAL

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.

Daridorexant; Placebo

MEMS and Medication Accounting DEVICE

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 adherence reports to research staff.

Daridorexant; Placebo

Contingency Management for Medication Adherence BEHAVIORAL

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.

Daridorexant; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Insomnia Severity Index (ISI) score equal or greater to 15 indicating the presence of moderate or severe insomnia
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sterling McPherson: lead
• University of Mississippi Medical Center: collaborator
• University of Kentucky: collaborator

Study Sites (1)

WSU Research Clinic

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Alcoholism; Sleep Initiation and Maintenance Disorders

Interventions

daridorexant; Micro-Electrical-Mechanical Systems

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Research Coordinator

CONTACT

509-638-2376; wsu.appl@wsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties involved with this clinical trial with the exception of our biostatistician and drug manufacturer will be blinded. Our biostatistician will be the only non-blinded research team member who will be in possession of the medication key, and they will not interact with participants. In case of emergency, the blind may be broken during office hours by a member of the research team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor/Vice Dean for Research

Model Details: Double-blind placebo controlled randomized clinical trial

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 5-6 years
• Access Criteria: Determined by NIAAA Data Archive Policy

Locations

US (1)