Daridorexant for People With Insomnia and Alcohol Use Disorder Study

Conditions

• Alcohol Use Disorder
• Insomnia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Jul 14, 2026

Start date

Sep 1, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2031

Study Design

Enrollment

205 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
• Experimental: Daridorexant

Primary Outcome Measure

Self-Reported Drinks Per Day and Heavy Drinking Days [ Time Frame: From enrollment to end of treatment at 12 weeks, and follow-up at 1-month, 6-months, and 1-year post treatment. ]

Central Contacts

• Research Coordinator
  509-638-2376
  [email protected]

Locations (1)

Find similar trials in Spokane, WA

Related Studies

• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Phoenix, Arizona
• CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms
  Recruiting · Johns Hopkins University · Eglin Air Force Base, Florida
• Virtual Incentive Treatment for Alcohol
  Recruiting · Washington State University · Spokane, Washington
• Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment
  Recruiting · Kaiser Permanente · Seattle, Washington