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This is a single blinded, randomized trial to evaluate the immediate subjective and objective effects of alcohol after a dose ketone supplement compared to a placebo in 10 health volunteers. Subjects will complete 2 lab visits where they consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%. Participants will randomly receive ketone supplement at one lab and the placebo at the next lab.
The purpose of the study is to evaluate the immediate subjective and objective effects of alcohol after consuming a ketone supplement beverage, compared to a placebo beverage (an inactive substance). Participants will not know which lab they receive the ketone drink, however they will be asked to drink an alcohol beverage (based on weight), to bring breath alcohol concentration (BrAC) to about 0.050% at each lab visit.
The goal of the study is to see how measure subjective effects of alcohol, once after drinking the ketone supplement and once after drinking a placebo beverage. The study will use questionnaires, blood, and breath alcohol tests to see how subjects body and brain experience alcohol. The study is also interested in if the ketone supplement makes people want to drink alcohol more or less.
Consent and Screening Session (approximately 3 hrs)
The following will occur at the screening session, following signed consent:
Staff will confirm eligible within 5 business days after the screening visit, to schedule the rest of the study visits.
Lab visits (approximately 5 1/2 hrs) The following will occur on the day of the two lab visits as a participant.
Table of assessments on Lab Visits:
Follow-up Visit (approximately 5 minutes): A follow-up phone call will occur the day after each lab visit and the following will occur:
• Staff will ask about any side effects that may have been experienced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketone supplement | Active Comparator | Subjects will drink single dose of ketone supplement 25g |
|
| Placebo beverage | Placebo Comparator | Subjects will drink single dose of placebo beverage that will look and taste the same as ketone supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Supplement | Dietary Supplement | Drink a single dose of ketone supplement 25g |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute effects of breath/blood alcohol levels in response to ketone supplement verse placebo | Change in breath/blood alcohol levels (grams per 210 Liters of breath) in response to ketone supplement verse placebo | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Acute effects of subjective reports of intoxication and alcohol craving in response to ketone supplement verse placebo after alcohol drinks. | Change in subjective effects are measured using the Drug Effects Questionnaire (DEQ): A 5-item scale assessing the extent to which participants (1) feel any DRUG EFFECTS, (2) feel HIGH, (3) LIKE the effects, (4) DISLIKE the effects, and (5) want MORE of the substance using a 100-mm visual analogue scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinde Wiers, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Center for Studies of Addiction | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C028491 | 1,3-butylene glycol |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Placebo controlled, randomized, crossover trial in 10 healthy volunteers
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Single blind
| Alcohol Beverage | Other | Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050% |
|
| 4 hours |