Alcohol Use DisorderPhase 2DIASNCT07701928
Daridorexant for People With Insomnia and Alcohol Use Disorder Study
A Phase 2 study testing Daridorexant, Brief Counseling and MEMS and Medication Accounting in people with Alcohol Use Disorder and Insomnia, run by Sterling McPherson at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Insomnia
- What is being tested?
- Daridorexant, Brief Counseling and MEMS and Medication Accounting
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
WSU Research Clinic
Spokane, Washington, 99202
509-638-2376, wsu.appl@wsu.edu
About this study
Official title: Daridorexant for the Treatment of Sleep Amongst Those With Alcohol Use Disorder Using the Addiction Neuroclinical Assessment Framework
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder, Insomnia
- Being tested
- Daridorexant, Placebo, Brief Counseling, MEMS and Medication Accounting, Contingency Management for Medication Adherence
- Keywords
- Alcohol Use Disorder, AUD, Contingency Management, Insomnia
- Medical subject headings
- Alcoholism, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 CounselingBehavioural
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 AdherenceBehavioural
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Behavioral: Brief Counseling; Device: MEMS and Medication Accounting; Behavioral: Contingency Management for Medication Adherence |
| Daridorexant | Experimental | Not described Receives: Drug: Daridorexant; Behavioral: Brief Counseling; Device: MEMS and Medication Accounting; Behavioral: Contingency Management for Medication Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Objectively verified total sleep time determined by electroencephalogram(EEG)
Measured: 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)
Measured: From enrollment through end of treatment at week 12, and follow-up at the 1-month, 6-months, and 1-year post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo controlled randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sterling McPherson
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, University of Mississippi Medical Center
- Responsible party
- Sponsor-investigator, Sterling McPherson, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701928
- Sponsor's protocol ID
- 26-0375
- Acronym
- DIAS
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared with NIAAA under required data archiving procedures.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daridorexant for the Treatment of Sleep Amongst Those With Alcohol Use Disorder Using the Addiction Neuroclinical Assessment Framework
- ClinicalTrials.gov ID
- NCT07701928
- Acronym / sponsor ID
- DIAS / 26-0375
- Conditions
- Alcohol Use Disorder, Insomnia
- Keywords
- Alcohol Use Disorder, AUD, Contingency Management, Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Sterling McPhersonUniversity, hospital or other
- Collaborators
- University of Kentucky, University of Mississippi Medical Center
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind placebo controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaridorexantDaridorexant 50mg (2 25mg tablets) taken once daily at night for the 12 week treatment phase. | Drug | Daridorexant |
| PlaceboPlacebo 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 | Drug | Placebo |
| Brief CounselingAll 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. | Behavioural | Daridorexant, Placebo |
| MEMS and Medication AccountingAll 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. | Device | Daridorexant, Placebo |
| Contingency Management for Medication AdherenceDuring 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. | Behavioural | Daridorexant, Placebo |
Primary outcome
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.
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.
Biochemically Verified Alcohol Use 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.
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.
2 secondary outcomes
Total Sleep Time
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. Data to be shared with NIAAA under required data archiving procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daridorexant, Brief Counseling and MEMS and Medication Accounting in people with Alcohol Use Disorder and Insomnia, run by Sterling McPherson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (509-638-2376, wsu.appl@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.