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Activated charcoal (AC) is an established, effective means of gastrointestinal decontamination. Providers give it to patients who have ingested something that is thought to be potentially poisonous to prevent it from being absorbed. However, one limitation to its use is palatability of the AC for the patient, potentially limiting how much, if any, is taken.
Other studies have suggested that mixing AC with various substances improves the rating on various scales (taste, etc). An important question is whether mixing the AC with other substance effects the ability of the AC to bind to xenobiotic in the gut. This small study investigates whether mixed cola with charcoal affected its ability to prevent the absorption of acetaminophen. It also performs a survery to see if participants preferred the AC-cola mixture. The investigators hypothesize that the AC will be equally as effective with cola as without. The investigators also hypothesize that participants will prefer the AC-cola mixture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activated charcoal with cola | Experimental |
| |
| Activated charcoal | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Charcoal | Drug | Activated charcoal alone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption of Acetaminophen as Indicated by Area Under the Curve | Measure of the area under the curve of the acetaminophen concentration vs time curve. Values obtained at 0, 15, 30, 45, 60, 75, 90, 120, 180, and 240 minutes were used to produce the curve | 240 minutes |
| Maximum Concentration Acetaminophen | Maximum concentration of acetaminophen (mcg/mL) | 240 minutes |
| Time to Maximum Concentration of Acetaminophen | Time of maximum concentration of acetaminophen (minutes) | 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Appeal of Charcoal Mixture | Participant rating of the appearance of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | 5 minutes |
| Smell of Charcoal Mixture |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University Clinical Research Unit | Syracuse | New York | 13210 | United States |
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All 5 screened participants met criteria for involvement in the study. Participants were randomized to receive either the charcoal or charcoal-cola mixture first, then, after at least 7 days between each session, the participants returned to complete the other arm of the study.
5 participants were screened for eligibility between January 4, 2023 and February 27, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Activated Charcoal With Cola First, Then Activated Charcoal Alone | Participants in this arm conducted the protocol with 50 g activated charcoal mixed with 240 mL of cola on study day 1. After a minimum of a 7 day washout period, they returned and repeated the protocol with 50 g activated charcoal alone. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Day 1 |
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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 | Nov 28, 2022 |
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| Activated Charcoal |
| Drug |
Activated charcoal mixed with cola |
|
Participant rating of the smell of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing
| 5 minutes |
| Flavor of Charcoal Mixture | Participant rating of the flavor of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | 5 minutes |
| Texture of Charcoal Mixture | Participant rating of the texture of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | 5 minutes |
| Overall Appeal of Charcoal Mixture | Participant rating of the overall appeal of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | 5 minutes |
| Activated Charcoal Alone First, Then Activated Charcoal With Cola |
Participants in this arm conducted the protocol with 50 g activated charcoal alone on study day 1. After a minimum of a 7 day washout period, they returned and repeated the protocol with 50 g activated charcoal mixed with 240 mL of cola. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout (at Least 7 Days) |
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| Study Day 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Activated Charcoal With Cola First | Participants received activated charcoal mixed with cola, then received activated charcoal alone |
| BG001 | Activated Charcoal Alone First | Participants received activated charcoal alone, then received activated charcoal mixed with cola |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| 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 | Absorption of Acetaminophen as Indicated by Area Under the Curve | Measure of the area under the curve of the acetaminophen concentration vs time curve. Values obtained at 0, 15, 30, 45, 60, 75, 90, 120, 180, and 240 minutes were used to produce the curve | Posted | Mean | 95% Confidence Interval | mcg*min/mL | 240 minutes |
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| Primary | Maximum Concentration Acetaminophen | Maximum concentration of acetaminophen (mcg/mL) | Posted | Mean | 95% Confidence Interval | mcg/mL | 240 minutes |
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| Primary | Time to Maximum Concentration of Acetaminophen | Time of maximum concentration of acetaminophen (minutes) | Posted | Mean | 95% Confidence Interval | minutes | 240 minutes |
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| Secondary | Appeal of Charcoal Mixture | Participant rating of the appearance of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | Posted | Mean | 95% Confidence Interval | score on a scale | 5 minutes |
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| Secondary | Smell of Charcoal Mixture | Participant rating of the smell of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | Posted | Mean | 95% Confidence Interval | units on a scale | 5 minutes |
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| Secondary | Flavor of Charcoal Mixture | Participant rating of the flavor of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | Posted | Mean | 95% Confidence Interval | score on a scale | 5 minutes |
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| Secondary | Texture of Charcoal Mixture | Participant rating of the texture of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | Posted | Mean | 95% Confidence Interval | score on a scale | 5 minutes |
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| Secondary | Overall Appeal of Charcoal Mixture | Participant rating of the overall appeal of charcoal mixture on a scale of 0 to 10, with 10 being the most appealing and 0 being the least appealing | Posted | Mean | 95% Confidence Interval | score on a scale | 5 minutes |
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Adverse events were recorded on study days 1 and 2, for the duration of the study day (Entirety of each study day approximately 240 minutes)
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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 | Activated Charcoal With Cola | Participants received activated charcoal mixed with cola (either first or after a | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | Activated Charcoal Alone | Activated charcoal alone first | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Keenan, MD | SUNY Upstate Department of Emergency Medicine | 315-416-4457 | keenanm@upstate.edu |
| May 3, 2024 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2022 | Mar 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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