Daridorexant for People With Insomnia and Alcohol Use Disorder Study

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

Interventions

DRUG

Daridorexant

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

DRUG

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

BEHAVIORAL

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.

DEVICE

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 adherence reports to research staff.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Kentucky

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• Sterling McPherson

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2030-12-31

Completion

2031-12-31

FDA Drug

Yes

Countries

• United States

Study Locations