Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy

Overdose Clinical Trial

Official title:

Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy: A Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06219967
• Other study ID #: 1783698-11
• Status: Completed
• Phase: Phase 4
• Start date: January 4, 2023
• Est. completion date: March 14, 2023

Study information

• Verified date: May 2024
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Overdose

Intervention

Drug:
• Activated Charcoal
Activated charcoal alone
• Activated Charcoal
Activated charcoal mixed with cola

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University Clinical Research Unit	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	240 minutes
Primary	Maximum Concentration Acetaminophen	Maximum concentration of acetaminophen (mcg/mL)	240 minutes
Primary	Time to Maximum Concentration of Acetaminophen	Time of maximum concentration of acetaminophen (minutes)	240 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	5 minutes
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	5 minutes
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	5 minutes
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	5 minutes
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	5 minutes