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| Name | Class |
|---|---|
| Idorsia Pharmaceuticals Ltd. | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daridorexant | Experimental | Daridorexant 50mg (Oral) |
|
| Placebo | Placebo Comparator | Placebo (Oral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daridorexant 50 mg | Drug | Daridorexant 50 mg (Orally administered) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time (Minutes) | 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. | Enrollment to one month follow-up |
| Alcohol Craving Visual Analogue Scale | Visual Analogue Scales assessing alcohol craving will be administered (Range 0-100, higher scores indicate greater craving). | Enrollment to one month follow-up |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ellis | Contact | 410-550-6346 | jellis36@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Ellis | Johns Hopkins University | Principal Investigator |
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Deidentified data will be shared via the NIAAA Data Archive following publication. Access will be controlled and require submission of a Data Access Request. Supporting documentation will also be provided.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000634383 | daridorexant |
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| Placebo |
| Other |
Placebo (Oral) |
|
| Number of Alcohol use disorder symptoms | 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. | Enrollment to one-month follow-up |
| Self-Reported Insomnia Severity | 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). | Enrollment to one-month follow-up |