OverdosePhase 4NCT06219967
Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy
A Phase 4 study testing Activated Charcoal in people with Overdose, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overdose
- What is being tested?
- Activated Charcoal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 14 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- pregnant,
- imprisoned
- allergy or intolerance to acetaminophen or gluten
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University Clinical Research Unit
Syracuse, New York, 13210
About this study
Official title: Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy: A Randomized Crossover Trial
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.
- Conditions
- Overdose
- Being tested
- Activated Charcoal
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated CharcoalDrug
Activated charcoal alone
Activated CharcoalDrug
Activated charcoal mixed with cola
| Study group | Role | What they receive |
|---|---|---|
| Activated charcoal with cola | Experimental | Not described Receives: Drug: Activated Charcoal |
| Activated charcoal | Active comparator | Not described Receives: Drug: Activated Charcoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 240 minutes
Maximum Concentration Acetaminophen
Maximum concentration of acetaminophen (mcg/mL)
Measured: 240 minutes
Time to Maximum Concentration of Acetaminophen
Time of maximum concentration of acetaminophen (minutes)
Measured: 240 minutes
Secondary outcomes (5)
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
Measured: 5 minutes
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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start4 Jan 2023
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Keenan, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219967
- Sponsor's protocol ID
- 1783698-11
- Status last verified
- May 2024
- First submitted
- 2 Jan 2024
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06219967
- Acronym / sponsor ID
- 1783698-11
- Conditions
- Overdose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activated charcoal with cola | Experimental | Drug: Activated Charcoal |
| Activated charcoal | Active comparator | Drug: Activated Charcoal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- pregnant,
- imprisoned
- allergy or intolerance to acetaminophen or gluten
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated CharcoalActivated charcoal alone | Drug | Activated charcoal |
| Activated CharcoalActivated charcoal mixed with cola | Drug | Activated charcoal with cola |
Primary outcome
Absorption of Acetaminophen as Indicated by Area Under the Curve
Time frame: 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
Time frame: 240 minutes
Maximum concentration of acetaminophen (mcg/mL)
Time to Maximum Concentration of Acetaminophen
Time frame: 240 minutes
Time of maximum concentration of acetaminophen (minutes)
5 secondary outcomes
Appeal of Charcoal Mixture
Time frame: 5 minutes
Smell of Charcoal Mixture
Time frame: 5 minutes
Flavor of Charcoal Mixture
Time frame: 5 minutes
Texture of Charcoal Mixture
Time frame: 5 minutes
Overall Appeal of Charcoal Mixture
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Activated Charcoal in people with Overdose, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absorption of Acetaminophen as Indicated by Area Under the Curve (time frame: 240 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.