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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA030775 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will be treated daily with an oral placebo. |
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| Suvorexant Dose 1 | Experimental | Subjects will be treated daily with oral suvorexant (10 mg). |
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| Suvorexant Dose 2 | Experimental | Subjects will be treated daily with oral suvorexant (20 mg). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reinforcing Effects of Alcohol | Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money | 6 times over approximately 3 week inpatient admission. |
| Measure | Description | Time Frame |
|---|---|---|
| Craving | Subjects will report their craving during 6 sessions while they are admitted to our inpatient unit. Measured using a 10 point craving questionnaire with higher scores meaning greater craving. | 6 times over approximately 3 week inpatient admission. |
| Mood |
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Inclusion/Exclusion Criteria:
All gender identities are eligible.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William W Stoops, PhD | Contact | 8592575388 | william.stoops@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| William W Stoops, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychopharmacology of Addiction Laboratory | Recruiting | Lexington | Kentucky | 40507 | United States |
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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 |
|---|---|
| D000431 | Ethanol |
| C551624 | suvorexant |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | The effects of placebo will be determined. |
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| Suvorexant | Drug | The effects of suvorexant dose 1 will be determined. |
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| Suvorexant | Drug | The effects of suvorexant dose 2 will be determined. |
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Subjects will complete the Profile of Mood States during 6 sessions while they are admitted to our inpatient unit. Scores range from 0 to 4 with higher scores indicating stronger mood. |
| 6 times over approximately 3 week inpatient admission. |
| Alcohol Response | Subjects will complete the Biphasic Alcohol Effects Scale during 6 sessions while they are admitted to our inpatient unit. Scores range from 0 to 10 with higher scores indicating greater responses. | 6 times over approximately 3 week inpatient admission. |
| Heart rate | Beats per minute. Measured daily during inpatient admission. | Daily over approximately 3 week inpatient admission. |
| Blood pressure | mm Hg. Measured daily during inpatient admission. | Daily over approximately 3 week inpatient admission. |
| Breath Alcohol Level | Percent. Measured daily during inpatient admission. | Daily over approximately 3 week inpatient admission. |
| Temperature | Degrees Fahrenheit. Measured daily during inpatient admission. | Daily over approximately 3 week inpatient admission. |
| Side Effects | Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications. | Daily over approximately 3 week inpatient admission. |
| Delay Discounting | Subjects will complete the delay discounting task during 6 sessions while they are admitted to our inpatient unit. Responses will be used to calculate discounting slope (i.e., K). | 6 times over approximately 3 week inpatient admission. |
| n-back Task | Subjects will complete the n-back task during 6 sessions while they are admitted to our inpatient unit. Percentage of correct responses will be the outcome. | 6 times over approximately 3 week inpatient admission. |
| Stop-Signal Task Inhibitory Failures | Subjects will complete the stop-signal task during 6 sessions while they are admitted to our inpatient unit. Proportion of inhibitory failures will be the outcome variable. | 6 times over approximately 3 week inpatient admission. |
| Sleep | Subjects will complete the St. Mary's Sleep Questionnaire daily while they are admitted to our inpatient unit. Total sleep time will be the outcome variable and will be recorded in minutes. Higher scores indicate more sleep. Total sleep time is measured by self-report; minimum score=0, maximum score=1440 per day. | Daily over approximately 3 week inpatient admission. |