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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
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This study plans to learn more about how alcohol and its metabolite, acetate, affect the brain.
This study plans to learn more about how alcohol and its metabolite, acetate, affect brain function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acetate arm | Experimental | IV acetate given during magnetic resonance scan |
|
| alcohol arm | Experimental | jello shots given before magnetic resonance scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetate | Drug | acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data. | fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs. |
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Inclusion Criteria-all:
Inclusion Criteria-moderate drinkers:
Inclusions-AUD:
(1) Subjects who meet DSM-V criteria for lifetime history of Alcohol Use Disorder (AUD)
Exclusion Criteria-all:
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| Name | Affiliation | Role |
|---|---|---|
| Jody L Tanabe, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31386214 | Result | Tanabe J, Yamamoto DJ, Sutton B, Brown MS, Hoffman PL, Burnham EL, Glueck DH, Tabakoff B. Effects of Alcohol and Acetate on Cerebral Blood Flow: A Pilot Study. Alcohol Clin Exp Res. 2019 Oct;43(10):2070-2078. doi: 10.1111/acer.14173. Epub 2019 Aug 24. |
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Dates: January 2016-March 2017 Target population: Healthy controls Method: Advertisements, flyers, word of mouth
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetate Arm | Placebo for 1 hour, then Acetate for 1 hour IV acetate given during magnetic resonance scan. acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan |
| FG001 | Alcohol Arm | Placebo for 1 hour, then Alcohol (given as a single dose of jello). jello given before magnetic resonance scan alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetate Arm | Placebo for 1 hour, then Acetate for 1 hour. IV acetate given during magnetic resonance scan acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan |
| BG001 | Alcohol Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling | cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data. | Posted | Mean | Standard Deviation | cc/100 mg/min | fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs. |
|
1 Day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetate Arm | IV acetate given during magnetic resonance scan acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
Data collection for an outcome measure related to brain activity during decision making before and after receiving alcohol or acetate was never completed due to feasibility and funding limitations and challenges encountered during the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jody Tanabe, MD | University of Colorado Denver | Anschutz | 3037241111 | clinicalresearchsupportcenter@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2017 | Jun 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000085 | Acetates |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
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| alcohol | Drug | a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan. |
|
|
Placebo for 1 hour, then alcohol (given as a single dose with jello).
jello given before magnetic resonance scan
alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Alcohol Arm |
jello shots given before magnetic resonance scan alcohol: a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan. |
| OG003 | Oral Placebo (Alcohol Arm) | Placebo given before Alcohol. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | IV Placebo (Acetate Arm) | Placebo given before Acetate. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Alcohol Arm | jello given before magnetic resonance scan alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Oral Placebo (Alcohol Arm) | Placebo given before Alcohol. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D000438 | Alcohols |