Overdose
Conditions
Brief summary
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.
Interventions
Activated charcoal alone
Sponsors
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* No self-reported history of any hepatic, gastrointestinal, or renal disease * No self-reported history of alcohol or substance use disorder * No daily prescribed medications * Weight between 60-93 kg
Exclusion criteria
* pregnant, * imprisoned * allergy or intolerance to acetaminophen or gluten
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absorption of Acetaminophen as Indicated by Area Under the Curve | 240 minutes | 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 |
| Maximum Concentration Acetaminophen | 240 minutes | Maximum concentration of acetaminophen (mcg/mL) |
| Time to Maximum Concentration of Acetaminophen | 240 minutes | Time of maximum concentration of acetaminophen (minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Texture of Charcoal Mixture | 5 minutes | 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 |
| Appeal of Charcoal Mixture | 5 minutes | 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 |
| Overall Appeal of Charcoal Mixture | 5 minutes | 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 |
| Smell of Charcoal Mixture | 5 minutes | 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 |
| Flavor of Charcoal Mixture | 5 minutes | 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 |
Countries
United States
Participant flow
Recruitment details
5 participants were screened for eligibility between January 4, 2023 and February 27, 2023.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Activated Charcoal With Cola First Participants received activated charcoal mixed with cola, then received activated charcoal alone | 3 |
| Activated Charcoal Alone First Participants received activated charcoal alone, then received activated charcoal mixed with cola | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Activated Charcoal With Cola First | Total | Activated Charcoal Alone First |
|---|---|---|---|
| Age, Continuous | 34 years | 32 years | 29 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 3 participants | 5 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Absorption of Acetaminophen as Indicated by Area Under the Curve | 3566 mcg*min/mL |
| Activated Charcoal Without Cola | Absorption of Acetaminophen as Indicated by Area Under the Curve | 3335 mcg*min/mL |
Primary
Maximum Concentration Acetaminophen
Maximum concentration of acetaminophen (mcg/mL)
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Maximum Concentration Acetaminophen | 33 mcg/mL |
| Activated Charcoal Without Cola | Maximum Concentration Acetaminophen | 29 mcg/mL |
Primary
Time to Maximum Concentration of Acetaminophen
Time of maximum concentration of acetaminophen (minutes)
Time frame: 240 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Time to Maximum Concentration of Acetaminophen | 51 minutes |
| Activated Charcoal Without Cola | Time to Maximum Concentration of Acetaminophen | 66 minutes |
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
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Appeal of Charcoal Mixture | 4.6 score on a scale |
| Activated Charcoal Without Cola | Appeal of Charcoal Mixture | 2.8 score on a scale |
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
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Flavor of Charcoal Mixture | 5.8 score on a scale |
| Activated Charcoal Without Cola | Flavor of Charcoal Mixture | 3.0 score on a scale |
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
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Overall Appeal of Charcoal Mixture | 4.4 score on a scale |
| Activated Charcoal Without Cola | Overall Appeal of Charcoal Mixture | 3.2 score on a scale |
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
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Smell of Charcoal Mixture | 5.8 units on a scale |
| Activated Charcoal Without Cola | Smell of Charcoal Mixture | 6.4 units on a scale |
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
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activated Charcoal With Cola | Texture of Charcoal Mixture | 4.4 score on a scale |
| Activated Charcoal Without Cola | Texture of Charcoal Mixture | 2.8 score on a scale |