Alcohol Use Disorder
Conditions
Brief summary
This study will test whether the dual orexin receptor antagonist (DORA) daridorexant reduces alcohol craving and use and improves total sleep time among patients with co-occurring alcohol use disorder and sleep disturbance. The study will assess the role of the orexin system in modulating alcohol craving and use in a real-world treatment setting.
Interventions
Daridorexant 50 mg (Orally administered)
OTHERPlacebo
Placebo (Oral)
Sponsors
Johns Hopkins University
Idorsia Pharmaceuticals Ltd.
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current moderate or severe DSM-5 criteria for AUD at the time of the screening session * Evidence of clinically significant sleep disturbance, based on the Pittsburgh Sleep Quality Index (PSQI; i.e., score \>5) * Aged 18 years or older * Willingness to comply with all components of the study protocol * Use of birth control throughout the study, if a pre-menopausal female who is not sterile, and who is sexually active with a male partner or considering being sexually active with a male partner * Report ability to access a computer with an internet connection during the outpatient phase of the study to complete virtual outpatient visits * Report a desire to quit or reduce drinking (i.e., not enrolling in treatment solely to satisfy an external requirement) * Able to provide informed consent, and evidence an understanding of study procedures based on a quiz following informed consent * Fluent in English (in order to complete study assessments).
Exclusion criteria
* Current moderate or severe substance use disorder other than AUD, cannabis use disorder, nicotine use disorder, or caffeine use disorder * Pregnant or breastfeeding, or planning to become pregnant during the study * Known allergy to any DORA * Past 30-day use of any DORA * Current use of benzodiazepines or other schedule IV medications for insomnia * Use of any medications that are contraindicated for use with daridorexant * Current withdrawal symptoms, as assessed by a score \>8 on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) and benzodiazepine administration in the past 24 hours * Past-year suicidal behavior * Current bipolar disorder or psychotic disorder * Abnormal liver enzyme levels (i.e., AST or ALT greater than five times above the upper limit of normal, or bilirubin greater than two times the upper limit of normal), as assessed during standard intake procedures at Ashley Addiction Treatment * AHI\>30, as assessed using a wireless EEG/apnea device, to rule out those with severe sleep apnea * Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements * Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time (Minutes) | Enrollment to one month follow-up | Total sleep time will be assessed through both wireless EEG and ambulatory monitoring. Wireless EEG will be assessed during the residential phase only. Ambulatory monitoring will occur during both the residential and outpatient phase. |
| Alcohol Craving Visual Analogue Scale | Enrollment to one month follow-up | Visual Analogue Scales assessing alcohol craving will be administered (Range 0-100, higher scores indicate greater craving). |
| Daily alcohol use, assessed via Timeline Followback (TLFB) | Outpatient phase (Day 1 post-residential treatment to one-month follow-up) | — |
| Number of Adverse Events | From enrollment to one month follow-up | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily binge drinking, assessed via Timeline Followback (TLFB) | Outpatient phase (Day 1 post-residential treatment to one-month follow-up) | — |
| Number of Participants with Positive breathalyzer screen | Outpatient phase (Day 1 post-residential treatment to one-month follow-up) | — |
| Number of Alcohol use disorder symptoms | Enrollment to one-month follow-up | Alcohol use disorder symptoms, assessed using the Alcohol Use Disorders module of the Mini-International Neuropsychiatric Interview. 9-items rated on a dichotomous Yes/No scale. |
| Self-Reported Insomnia Severity | Enrollment to one-month follow-up | Self-reported insomnia severity, assessed using the Insomnia Severity Index. Each item is scored 0 (no problem) - 4 (very big problem) likert scale with total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). |
Contacts
CONTACTJennifer Ellis
PRINCIPAL_INVESTIGATORJennifer Ellis
Johns Hopkins University
Outcome results
None listed