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

Phase 4

Completed

• Conditions: Overdose
• Interventions: Drug: Activated Charcoal

• Registration Number: NCT06219967
• Lead Sponsor: State University of New York - Upstate Medical University

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

Not available

Study Timeline

• Study Start: 2023-01-04
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-14
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Results First Submitted: 2024-03-12
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Results First Posted: 2024-05-30
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

• pregnant,
• imprisoned
• allergy or intolerance to acetaminophen or gluten

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Activated charcoal	Activated Charcoal	-
Activated charcoal with cola	Activated Charcoal	-

Primary Outcome Measures

Name	Time	Method
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
Time to Maximum Concentration of Acetaminophen	240 minutes	Time of maximum concentration of acetaminophen (minutes)
Maximum Concentration Acetaminophen	240 minutes	Maximum concentration of acetaminophen (mcg/mL)

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

SUNY Upstate Medical University Clinical Research Unit; 🇺🇸 Syracuse, New York, United States