Clinical trial NCT06219967
Conditions: Overdose
Sponsor: State University of New York - Upstate Medical University
Start date: 2023-01-04; Completion date: 2023-03-14
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Activated Charcoal intervention 2: Activated Charcoal
Intervention descriptions: intervention 1: Activated charcoal alone intervention 2: Activated charcoal mixed with cola

Protocol documents:
ICF_001.pdf: 
 
1 
 Version Date: 11/28/2022 
 
Title: Does a soft drink mixture improve tolerance of activated charcoal in an 
adult without affecting efficacy: A randomized controlled crossover study 
 
Clinical Trials Number: NCT06219967 
 
Document Date: 11/28/22 


 
2 
 Version Date: 11/28/2022 
 
 
RESEARCH SUBJECT CONSENT & AUTHORIZATION FORM 
Title: 
Does a soft drink mixture improve tolerance of activated charcoal 
in an adult without affecting efficacy: A randomized controlled 
crossover study 
Investigator: 
Michael Keenan, MD 
 
750 East Adams St 
 
Syracuse, NY 13210 
Daytime Phone Number: 
315-416-4457 
24-hour Phone Number: 
315-416-4457 
 
RESEARCH CONSENT SUMMARY 
You are being asked for your consent to take part in a research study. This document provides a 
concise summary of this research. It describes the key information that we believe most people 
need to decide whether to take part in this research. Later sections of this document will provide 
all relevant details. 
What should you know about this research? 
• Someone will explain this research to you. 
• This form sums up that explanation. 
• Taking part in this research is voluntary. Whether you take part is up to you. 
• If you don’t take part, it won’t be held against you. 
• You can take part now and later drop out, and it won’t be held against you 
• If you don’t understand, ask questions. 
• Ask all the questions you want before you decide. 
How long will you be in this research? 
We expect that your taking part in this research will last _10__ hours 
Why is this research being done? 
The purpose of this research is to determine if a soft drink and activated charcoal mixture adequately 
reduces systemic absorption in healthy adults who have taken a supratherapeutic dose of acetaminophen 
in addition to improving its tolerance. 


 
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What happens to you if you agree to take part in this research? 
If you decide to take part in this research study, the general procedures include ingesting a pre-
determined amount of acetaminophen (Tylenol), followed by activated charcoal. After that, 
blood work will be obtained to check the acetaminophen levels in your blood. This will take 
approximately 5 hours. You will then return to repeat the study, allowing us to compare charcoal 
by itself with charcoal mixed with a soft drink.  
Could being in this research hurt you? 
The most important risks or discomforts that you may expect from taking part in this research 
include pain from IV insertion, nausea or discomfort from the taste of the charcoal. It is 
important to note that as part of the study, you will be taking more acetaminophen than you 
would typically ingest. The amount you will take is well below the toxic dose. We have extra 
safeguards in place to ensure no one receives a toxic dose of acetaminophen. 
Will being in this research benefit you? 
It is not expected that you will personally benefit from this research 
Possible benefits to others include improved management of poisoned patients in the future by 
providing a more palatable vehicle for charcoal administration, which can reduce the amount of 
poison they are exposed to.  
What else should you know about this research? 
Other information that may be important for you to consider so you can decide whether to take 
part in this research is that you will need to abstain from alcohol the day before, day of, and day 
after the study. You will also be asked to avoid acetaminophen for 5 days before, day of, and 5 
days after the study.  
DETAILED RESEARCH CONSENT 
You are being invited to take part in a research study.  A person who takes part in a research 
study is called a research subject, or research participant.  
Why is this research being done? 
To determine if a soft drink and activated charcoal mixture adequately reduces systemic absorption in 
healthy adults who have taken a supratherapeutic dose of acetaminophen in addition to improving its 
tolerance. 
About 5 subjects will take part in this research. 
What happens to you if you agree to take part in this research? 
PROCEDURES 


 
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If you volunteer to participate in this study, you will be asked to come in for three different visits.  
Visit 1 (today) 
Here, we will obtain a consent form and a screening form to determine eligibility for the study. 
Visit 2 
Please arrive by 8AM after an overnight fast to have commenced at 4 am. Your age will be recorded and 
your height and weight will be measured in order to calculate your BMI.  
Following this, you will be fed a light breakfast of 2 pieces of dry toast and 200 mL of water. A 
peripheral IV will be placed in the antecubital fossa for blood drawing. The area will be cleaned with an 
alcohol wipe and a tourniquet will be placed on the arm proximal to planned IV insertion site.   
One hour after breakfast, you will be given 50mg/kg of acetaminophen (Tylenol) along with 150 mL of 
water in the form of 325 mg tablets. The purpose of doing this is to more closely mimic the overdose 
setting.  
One hour after the acetaminophen consumption, you will be given the charcoal mixture. You will be 
given either 50 g of Actidose-aqua, a pre-mixed charcoal-water slurry, OR 50 g of Actidose-aqua in 
addition to 240 mL of a soft drink. You will be asked to rate the appearance, smell, flavor, texture, ability 
to swallow, and overall appeal of the charcoal mixture on a scale of 1-10, with 1 being the worse and 10 
being the best.  
We will draw your blood ten times in a gold or mint tube after ingestion of the charcoal mixture. The first 
will be at time 0 (time of consumption of the mixture). The next will be at 15, 30, 45, 60, 75, 90, 120, 
180, 240 minutes. These samples will be taken to the lab for processing. 
You will receive a light snack of crackers and water no sooner than 3 hours after the charcoal was 
consumed (4 hours after ingestion of the acetaminophen). 
Visit 3 
Please arrive by 8AM after an overnight fast to have commenced at midnight the night prior. Your age 
will be recorded and your height and weight will be measured in order to calculate your BMI.  
Following this, you will be fed a light breakfast of 2 pieces of dry toast and 200 mL of water. A 
peripheral IV will be placed in the antecubital fossa for blood drawing. The area will be cleaned with an 
alcohol wipe and a tourniquet will be placed on the arm proximal to planned IV insertion site.   
One hour after breakfast, you will be given 50mg/kg of acetaminophen (Tylenol) along with 150 mL of 
water in the form of 325 mg tablets. The purpose of doing this is to more closely mimic the overdose 
setting.  
One hour after the acetaminophen consumption, you will be given the charcoal mixture. You will be 
given the other mixture that you did not receive during Visit 2, that is, either 50 g of Actidose-aqua, a pre-
mixed charcoal-water slurry, OR 50 g of Actidose-aqua in addition to 240 mL of a soft drink. You will be 
asked to rate the appearance, smell, flavor, texture, ability to swallow, and overall appeal of the charcoal 
mixture on a scale of 1-5, with 1 being the worse and 5 being the best.  


 
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We will draw your blood ten times in a gold or mint tube after ingestion of the charcoal mixture. The first 
will be at time 0 (time of consumption of the mixture). The next will be at 15, 30, 45, 60, 75, 90, 120, 
180, 240 minutes. These samples will be taken to the lab for processing. 
You will receive a light snack of crackers and water no sooner than 3 hours after the charcoal was 
consumed (4 hours after ingestion of the acetaminophen). 
What are your responsibilities if you take part in this research? 
If you take part in this research, you will be responsible to: 
• Avoid alcohol the day before, day of, and day after the study 
• Avoid acetaminophen for 5 days before, day of, and 5 days after 
Could being in this research hurt you? 
You may experience some discomfort with IV insertion. You may experience nausea or vomiting 
with the charcoal administration.  
Acetaminophen in overdose can lead to liver injury. However, the amount you will be ingesting 
(40 mg/kg) is well below the toxic dose of 150 mg/kg. In addition, weight cutoffs in place will 
not allow any participant to receive more than 4g of acetaminophen, the recommended max daily 
dose. The weight cutoffs are such that even if the patient who weights the least accidently 
received the dose intended for the smallest person, it would still not exceed 150 mg/kg (max 
weight allowed 3X the weight of the smallest participant). Finally, as an added level of security, 
a 4-hour acetaminophen level will be drawn, which will be used to ensure that your 
acetaminophen level is not toxic. If, for some reason, it was toxic (which would only occur if 
there was a dosing error), there is an antidote which is essentially nearly 100% effective if given 
within 8 hours.  
In addition to these risks, taking part in this research may harm you in unknown ways. 
Will it cost you money to take part in this research? 
No, outside of transportation/parking costs 
Will being in this research benefit you? 
There are no benefits to you from your taking part in this research. We cannot promise any 
benefits to others from your taking part in this research. However, possible benefits to others 
include improvement in the care of poisoned patients. 
What other choices do you have besides taking part in this research? 
Your alternative is to not take part in the research. 


 
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What happens to the information or specimens collected for this 
research? 
Your information or samples that are collected as part of this research will not be used or 
distributed for future research studies, even if all of your identifiers are removed. 
Who can answer your questions about this research? 
If you have questions, concerns, or complaints, or think this research has hurt you or made you 
sick, talk to the research team at the phone number listed above on the first page. 
This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of 
people who perform independent review of research studies. You may talk to them at (315) 464-
4317 if: 
• You have questions, concerns, or complaints that are not being answered by the research 
team. 
• You are not getting answers from the research team. 
• You cannot reach the research team. 
• You want to talk to someone else about the research. 
• You have questions about your rights as a research subject. 
What if you are injured because of taking part in this research? 
In the event of a research related injury, treatment is available at University Hospital but is not 
free of charge. The costs will be billed to you or your insurance company in the usual fashion.  
SUNY Upstate Medical University has no funds set aside to compensate you for injuries. You 
have not waived any of your legal rights by signing this form. 
Can you be removed from this research without your approval? 
The person in charge of this research can remove you from this research without your approval. 
Possible reasons for removal include:  
• It is in your best interest 
• You have a side effect that requires stopping the research 
• You need a treatment not allowed in this research 
• You become pregnant 
• You are unable to take the research medication 
• You are unable to keep your scheduled appointments 
We will tell you about any new information that may affect your health, welfare, or choice to 
stay in this research. 


 
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What happens if you agree to be in this research, but you change 
your mind later? 
If you decide to leave this research, contact the research team so that the investigator can be 
removed from the study. There are no risks to leaving early 
Will you be paid for taking part in this research? 
For taking part in this research, if you complete all parts of the study, you will be paid $150. 
Your compensation will be broken down as follows: 
• Participants will receive a Visa gift card within 14 days of the final study day 
• If participants do not complete the entire study, they will not receive compensation 
 
By accepting payment for participating in this study, identifying information about you (such as 
your full name and social security number) needs to be collected and may be shared with 
auditors and the finance office to ensure compliance with Internal Revenue Service (IRS) 
requirements.  If you do not want to provide this information for payment reasons, you have the 
option to decline the payment and still participate in the study.  Please note that if you earn $600 
or over in a calendar year as a research subject, you may have to pay taxes on these earnings.  
Information provided for payment purposes will be kept confidential. 
Confidentiality of records and authorization to use/share protected 
health information for research:  
If you agree to participate in this research, identifiable health information about you will be used 
and shared with others involved in this research. For you to be in this research we need your 
permission to collect and share this information. Federal law protects your right to privacy 
concerning this information.  
 
When you sign this consent form at the end, it means that you have read this section and 
authorize the use and/or sharing of your protected health information as explained below. Your 
signature also means you have received a copy of Upstate’s Notice of Privacy Practices.  
 
Individually identifiable health information under the federal privacy law is considered to be any 
information from your medical record, or obtained from this study, that can be associated with 
you, and relates to your past, present, or future physical or mental health or condition. This is 
referred to as protected health information. 
 
Your protected health information will be kept confidential. Your identity will not be revealed in 
any publication or presentation of the results of this research. 
 
Why is it necessary to use/share your protected health information with others? 
The main reason to use and share your health information is to conduct the research as described 
in this consent form. Your information may also be shared with people and organizations that 
make sure the research is being done correctly, and to report unexpected or bad side effects you 
may have. 


 
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In addition, we may be required by law to release protected health information about you; for 
example, if a judge requires such release in a lawsuit, or if you tell us of your intent to harm 
yourself or others. 
 
What protected health information about you will be used or shared with others as part of this 
research? 
We may use and share the results of tests, questionnaires, and interviews. We may also use and 
share information from your medical and research records. We will only collect information that 
is needed for the research. 
 
Who will be authorized to use and/or share your protected health information? 
The researchers, their staff and the staff of Upstate Medical University participating in the 
research will use your protected health information for this research study. In addition, the 
Upstate Institutional Review Board (IRB), a committee responsible for protecting the rights of 
research subjects, and other Upstate Medical University or University Hospital staff who 
supervise the way the research is done may have access to your protected health information.  
 
The researchers and their staff will determine if your protected health information will be used or 
shared with others outside of Upstate Medical University for purposes directly related to the 
conduct of the research. 
 
With whom would the protected health information be shared? 
 
Your protected health information will not be shared 
All reasonable efforts will be used to protect the confidentiality of your protected health 
information. However, not all individuals or groups have to comply with the Federal privacy 
law. Therefore, once your protected health information is disclosed (leaves Upstate Medical 
University), the Federal privacy law may not protect it.   
For how long will your protected health information be used or shared with others? 
There is no scheduled date at which this information will be destroyed or no longer used. This is 
because information that is collected for research purposes continues to be used and analyzed for 
many years and it is not possible to determine when this will be complete. 
 
Can you withdraw your authorization to collect/use/share your protected health information? 
You always have the right to withdraw your permission (revoke authorization) for us to use and 
share your health information, by putting your request in writing to the investigator in charge of 
the study.  This means that no further private health information will be collected. Once 
authorization is revoked, you may no longer participate in this research activity, but standard 
medical care and any other benefits to which you are entitled will not be affected. Revoking your 
authorization only affects uses and sharing of information obtained after your written request has 
been received, but not information obtained prior to that time. 
 


 
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Even after you withdraw your permission, Upstate Medical University may continue to use and 
share information needed for the integrity of the study; for example, information about an 
unexpected or bad side effect you experienced related to the study. 
 
Can you have access to your health information? 
At the end of the study, you have the right to see and copy health information about you in 
accordance with the SUNY Upstate Medical University policies; however, your access may be 
limited while the study is in progress. 
Statement of Consent to Participate in Research & Authorization to 
use and share personal health information 
• 
Participation in this study is entirely voluntary. You can choose not to take part. There will 
be no penalty or loss of benefits to which you are otherwise entitled.  
• 
If you agree to take part and later change your mind. There will be no penalty or loss of 
benefits to which you are otherwise entitled. 
• 
I have read this information and this study has been explained to me.  
• 
It has been written in a language that I understand.   
• 
All my questions about the study have been answered to my satisfaction.   
 
 
For Subjects 18 Years Of Age And Older 
 
I hereby give my consent to participate in this research study and agree that my personal health 
information can be collected, used and shared by the researchers and staff for the research study 
described in this form. I will receive a signed copy of this consent form.  
 
______________________________________ 
 
 
 
_______________ 
Signature of subject     
 
 
 
 
 
 
Date 
 
___________________________________________ 
 
 
_______________ 
Signature of Person Obtaining Consent/Authorization 
 
 
Date 
 
_________________________________________  
 
Name of Person Obtaining Consent/Authorization 
 
 
 
 

Prot_SAP_002.pdf: 
 
Title: Does a soft drink mixture improve tolerance of activated charcoal in an 
adult without affecting efficacy: A randomized controlled crossover study 
 
Clinical Trials Number: NCT06219967 
 
Document Date: 11/28/22 


Background 
Activated charcoal has become an established component of gastrointestinal 
decontamination in the poisoned patient.1 While the exact methods vary by manufacturer, 
the basic production process involves pyrolysis of organic material followed by exposure to 
an oxidizing gas at high temperature.2 This results in a compound with a very large surface 
area – 800-1200 m2/g.3 Charcoal as a compound has been around for thousands of years, 
being used for heating and cooking for thousands of years.4 The compounds ability to 
adsorb chemicals gradually began to be known. In 1773 organic chemist Carl Wilhelm 
Scheele used charcoal to absorb gases. In 1830, a French pharmacist named Touery 
survived after swallowing a lethal dose of strychnine with charcoal to prove its ability to 
adsorb poisons.    
The eLicacy of charcoal, though historically debated, has become rather well 
established. It has become a staple in the management of the poisoned patient. Numerous 
studies have proven that activated charcoal administration decreases the adsorption of 
xenobiotic from the gut in an overdose.4-10 These have been done in both volunteer subjects 
and in poisoned patients. In addition, some studies have gone beyond simply looking at 
pharmacokinetic data and have looked at clinical outcome data. Although a detailed 
review of the literature is beyond the scope of this background section, several studies will 
be brieﬂy reviewed here. In a study by Christophersen et al, healthy volunteers were given a 
sub-toxic dose of acetaminophen.5 They discovered that charcoal signiﬁcantly reduced the 
amount of acetaminophen absorbed from the gut when given at both 1 hour post-ingestion 
and 2 hours post-ingestion. However, the reduction was less signiﬁcant when charcoal was 
given 2 hours post-ingestion compared to one hour post-ingestion, emphasizing the need 
to administer charcoal as early as possible post-ingestion. Another study by Yeates and 
Thomas looked at healthy volunteers given a sub-toxic dose of acetaminophen with 
charcoal administered at 1, 2, or 4 hours post-ingestion. They found a signiﬁcant reduction 
in absorption of acetaminophen when charcoal was given 1 or 2 hours post-ingestion, but 
not 4 hours.6 A study by Isbister et al looked at patients after intentional ingestion of 
citalopram.7 They found that charcoal those that received charcoal were less likely to 
experience a prolonged QT on EKG. Finally, a study by Underhill et al looked at patients 
presenting after an intentional ingestion of acetaminophen and randomized them to 
diLerent methods of GI decontamination: gastric lavage, activated charcoal, ipecacuanha, 
or no decontamination. They found that activated charcoal was the most eLective 
decontamination method.8  
Despite the apparent beneﬁt of activated charcoal, one of the main limitations to its 
use is its taste and appearance. As such, numerous studies have looked at diLerent 
mixtures to try to improve the taste/appearance of the charcoal.12-15 The results of these 
studies are mixed, but, for the most part, ﬁnd that charcoal is better received if it is mixed in 


something like cola or chocolate milk. However, the caveat is that some of these vehicles 
used to improve the palatability of the charcoal may decrease its ability to adsorb 
xenobiotic. Ice cream has been found to decrease the eLicacy of the charcoal.16 Jam has 
been found to not aLect the eLicacy of the charcoal.17 Chocolate syrup has had mixed 
resulted.18-19 Yogurt was found to not aLect the eLicacy of the charcoal in vivo but did aLect 
the eLicacy in vitro.15  
Despite several taste test studies looking at the eLects of cola in improvement in 
palatability of charcoal, there does not appear to be any studies looking to see if cola 
aLects the eLicacy of charcoal. This is likely the most likely mixture in the Emergency 
Department as soft drinks are readily available in the patient nourishment supplies. 
In addition, there are no studies to our knowledge looking at comparison between 
clear and opaque containers in charcoal tolerance. There also are not any randomized 
controlled trials in poisoned patients. This study will be a pilot study to demonstrate that 
mixing charcoal with cola does not aLect the eLicacy of the charcoal, allowing us to 
continue on to the randomized controlled trial.  
 
References  
1. Smith SW, Howland M. Activated Charcoal. In: Nelson LS, Howland M, Lewin NA, Smith 
SW, Goldfrank LR, HoLman RS. Eds. Goldfrank’s Toxicologic Emergencies, 11e New York, 
NY: McGraw-Hill. 
2. 
Paddock Laboratories LRLPC. Actidose-Aqua & Actidose ® with Sorbitol. Actidose ® 
with Sorbitol. Actidose ®-Aqua. Activated Charcoal Suspension [product label]. 
Minneapolis, MN: Paddock Laboratories, LLC; 2014.  
3. 
Olson KR. Activated Charcoal for acute poisoning: one toxicologist’s journey. J Med 
Toxicol. 2010;6:190-198.  
4. 
Olson KR. Activated charcoal for acute poisoning: one toxicologist’s journey. J Med 
Toxicol. 2010; 6:190-198. 
5. 
Marketos SG, Androutsos G. Charcoal: from antiquity to artiﬁcial kidney. J Nephrol. 
2004;17:453-456.  
6. 
Christophersen AB, Levin D, Hoegberg LCG, Angelo HR, Kampmann JP. Activated 
charcoal alone or after gastric lavage: a simulated large paracetamol intoxication. Br J Clin 
Pharmacol. 2002;53:312-317 
7. 
Yeates PJA and Thomas SHL. ELectiveness of delayed activated charcoal 
administration in simulated paracetamol (acetaminophen) overdose. Br J Clin Pharmacol. 
2000;49:1-14.  
8. 
Isblster GK, Friberg LE, Stokes B, Buckley NA, Lee C, Gunja N, Brown SG, 
MacDonald E, Graudlins A, Holdgate A, DuLull SB. Activated charcoal decreases the risk of 


QT prolongation after citalopram overdose. Annals of Emergency Medicine. 
2007;50(5):593-600. 
9. 
Underhill TJ, Greene MK, Dove AF. A comparison of the eLicacy of gastric lavage, 
ipecacuanha, and activated charcoal in the emergency management of paracetamol 
overdose. Archives of Emergency Medicine. 1990. 7:148-154. 
10. 
Buckley NA, Whyte IM, O’Connell DL, Dawson AH. Activated charcoal reduces the 
need for N-acetylcysteine treatment after acetaminophen (paracetamol) overdose. Clinical 
Toxicology 1999;37(6):753-757. 
11. 
Friberg LE, Isbister GK, DuLull SB. Pharmacokinetic-pharmacodynamic modelling 
of QT interval prolongation following citalopram overdoses. Br J Clin Pharmacol. 
2005;61(2):177-190. 
12. 
Cheng A, Ratnapalan S. Improving the palatability of activated charcoal in pediatric 
patients. Pediatric Emergency Care. 2007;23(6):384-386. 
13. 
Dagnone D, Matsui D, Rieder MJ. Assessment of the palatability of vehicles for 
activated charcoal in pediatric volunteers. Pediatric Emergency Care. 2002;18(1):19-21. 
14. 
Skokan EG, Junkins EP, Corneli HM. Taste test: children rate ﬂavoring agents used 
with activated charcoal. Arch Pediatr Adolesc Med. 2001;155(6):683-686.  
15. 
Hoegberg LCG, Christophersen AB, Christensen HR, Angelo HR. Comparison of the 
adsorption capacities of an activated-charcoal-yogurt mixture versus activated-charcoal-
water slurry in vivo and in vitro. Clinical Toxicology. 2005;43:269-275. 
16. 
Levy G, Soda DM, Lampman TA. Inhibition by ice cream of the antidotal eLicacy of 
activated charcoal. Amer J Hosp Pharm. 1975;32:289-291.  
17. 
Neve, RE. Antidotal eLicacy of activated charcoal in presence of jam, startch, and 
milk. Am J Hosp Pharm. 1976;33:965-966.  
18. 
Scholtz EC, JaLe JM, Colaizzi JL. Evaluation of ﬁve activated charcoal formulations 
for inhibition of aspirin absorption and palatability in man. Am J Hosp Pharm. 
1978;35:1355-1359. 
19. 
Navarro KR, Krenzelok EP. Relative eLicacy and palatability of three activated 
charcoal mixtures. Veterinary and human toxicology. 1980;22(1):6-9. 
 
Protocol:  
 
Recruitment: 5 subjects will be recruited through ﬂyers and word of mouth.  
 
Inclusion: Healthy non-pregnant adults ages 18-40 
 
Exclusion: 
• Self-reported history of any hepatic, gastrointestinal, or renal disease. 


• Self-reported history of alcohol or drug abuse (deﬁned as any use of illicit drugs, 
alcohol use greater than the CDC standard recommended amount of 2 drinks per 
day in men). 
• Any current daily prescription medication use 
• Any allergy to Tylenol 
• Pregnant women 
• Age <18 or >40 
• Any gluten allergy or intolerance  
• Weight <60 kg or >93 kg 
• Prisoners 
• Adults unable to consent 
 
Participants will be provided the inclusion and exclusion criteria when they contact an 
investigator about the study.  Inclusion/exclusion criteria are conﬁrmed and documented at 
each protocol visit. We will use a screening questionnaire to access potential subjects 
based on the inclusion/exclusion criteria 
 
Settings 
The Clinical Research Unit in the Institute for Human Performance will be used to conduct the 
study. For screening, discussion of private information will be performed over the phone from a 
private office in the Poison Control Center.  
 
Study Day Method/Procedure: 
 
Visit 1  
a. This will be done over the phone from a private office in the Poison Control 
Center 
b. Will review inclusion/exclusion criteria to look at eligibility 
c. If done in person, will obtain signed consent  
 
The following will be collected at the start of visit 2 
a. Age 
b. Weight measured 
Visit 2 and 3 
a. If not already signed on visit 1, consent forms will be signed before 
initiation of the study 


b. Participants will be told in advance not to consume any alcohol the day 
before, day of, or day after the experiment 
c. Women will complete a pregnancy test on arrival to ensure exclusion 
criteria are not met.  
d. Participants will be told in advance not use consume and products 
containing acetaminophen the 5 days before, day of, and 5 days after the 
experiment 
e. Participants arrive at 8 AM after an overnight fast to have commenced at 
4am. They will have refrained from using acetaminophen for 5 days prior 
to the study. 
f. Participants will have their age and weight measured.  
g. Subjects will be fed a light breakfast of 2 pieces of dry toast and 200 mL of 
water 
h. A peripheral IV will be placed in the antecubital fossa for blood draws 
i. Area will be cleaned with an alcohol wipe 
ii. Tourniquet will be placed on the arm proximal to planned IV 
insertion site 
iii. IV tubing will be prepped with a saline flush 
iv. Vein will be accessed with an angiocath IV catheter (needle size 
determined by the nurse) 
v. Prepped IV tubing will be connected to the catheter and the line 
will be secured to the skin with a tegaderm.  
i. Acetaminophen ingestion will occur 1 hour after completion of the 
breakfast 
i. 45 mg/kg acetaminophen will be administered with 150 mL of 
water. The number of tablets will be rounded down to the nearest 
whole number 
ii. 325 mg tablets will be utilized to increase the gut burden of tablets 
to more closely mimic the overdose setting. The number of tablets 
will be rounded down to the nearest whole number 
iii. A max weight of 93 kg will be set for the participants. With this 
max weight, a participant at the max weight of 93 kg would be 
expected to ingest 4185 mg of Tylenol. However, as we are 
rounding down to the nearest tablet, they would only ingest 3,900 
mg of Tylenol, below the 4g recommended daily limit. 
j. Subjects will consume the charcoal mixture 1 hour after consumption of 
the acetaminophen tablets. Using a random number generator, 
participants will be assigned to either the control charcoal of the soda-
charcoal mix for the first experimental day. 


i. For the control day, 50 g activated charcoal will be administered 
by itself. Actidose-aqua, a pre-mixed charcoal-water slurry, will be 
used 
ii. For the study day, 50 g activated charcoal (Actidose-aqua) will be 
administered as a mixture with 240 cc soft drink (1:1 charcoal to 
soft drink). Actidose-aqua will be used  
k. Subjects will rate the appearance, smell, flavor, texture, and overall 
appeal of the charcoal mixture on a 1-10 scale, 10 being the best and 1 
being the worst. 
l. Blood for acetaminophen assay will be drawn in a Gold or Mint tube 
(approximately 5 mL per tube) at 0, 15, 30, 45, 60, 75, 90, 120, 180, 240, 
minutes 
i. Samples will be taken to the lab for processing 
ii. Samples will be run using Abbott’s Acetaminophen L3K assays 
(enzymatic colometric assay) 
m. Subjects will receive a light snack of crackers and water no sooner than 3 
hours after the charcoal is consumed (4 hours after acetaminophen was 
ingested).  
n. Participants will be reminded to refrain from using acetaminophen for 5 
days after the study 
 
Statistical Analysis 
DiLerences in all measures on the palatability questionnaire will be analyzed using a paired 
sample t-test with 95% conﬁdence intervals.   
 
To analyze diLerences in the pharmacokinetics between the study arms, the area under the 
curve, time of maximum concentration, and maximum concentration will be obtained. 
Area under the curve is used as a marker of drug absorption and will be calculated utilizing 
the trapezoidal rule. A paired t-test will be performed for comparison with 95% conﬁdence 
intervals.   
 
To compare the mg/kg dosing of acetaminophen for each arm of the study, a paired sample t-test 
will be performed. 
 
All analysis will be conducted using  IBM SPSS Version 26. The level of signiﬁcance was set 
at a p-value <0.05.