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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA032711 | 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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The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are:
Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Individuals will take a placebo pill daily for 8-weeks. |
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| Suvorexant | Experimental | Individuals will take 10mg of suvorexant (Merck & Co Inc.) daily for 8-weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant 10 mg | Drug | This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4 weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Heavy Drinking Days | Self-reported heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measured as proportion of heavy drinking days. | 8-week treatment period |
| Startle eyeblink potentiation | Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity. | Baseline; 4-weeks; 8-weeks |
| Alcohol Craving Via Ecological Momentary Assessment (EMA) | Participants will rate the intensity of their alcohol cravings using a Likert scale of 1 (lowest craving) -7 (highest craving). | 8-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Drinks Per Day | Self-reported total number of alcoholic drinks per day of the trial. | 8-week treatment period |
| Proportion of Days Abstinent | Self-reported proportion of days that individuals were abstinent from alcohol use. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Gorka | Contact | 614-366-1027 | stephanie.gorka@osumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
De-identified data from this project will be submitted to the NIAAA Data Archive (NDA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. The investigators will follow instructions as discussed in the NIAAA Data Archive Data Sharing Terms and Conditions.
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The data will be submitted to the NIAAA Data Archive biannually per NIAAA requirements throughout the duration of the study.
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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 |
|---|---|
| C551624 | suvorexant |
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| Placebo | Other | This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial. |
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| 8-week treatment period |
| Transdermal Alcohol Concentration (TAC) | Participants' TAC will provide an objective estimate of alcohol consumption each day. | 8-week treatment period |
| Phosphatidylethanol (PEth) levels | PEth will be measured from plasma samples at the mid-point and end-point. PEth is an objective biomarker of recent alcohol consumption. | 4-weeks; 8-weeks |
| Subjective Stress Levels via Ecological Momentary Assessment | Participants will rate their subjective stress levels using a Likert scale of 1 (least stress) - 5 (most stress). | 8-week treatment period |