Daridorexant for People With Insomnia and Alcohol Use Disorder Study

Phase 2Not Yet RecruitingNCT07701928

Sterling McPherson205 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

DaridorexantDRUG

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

PlaceboDRUG

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 CounselingBEHAVIORAL

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 AccountingDEVICE

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 AdherenceBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

Total Sleep Time

Objectively verified total sleep time determined by electroencephalogram(EEG)

Time frame: 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

Participants will self-report quality of sleep and daytime function using questionnaires like the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)

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