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

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.

Study Overview

• Status: Completed
• Conditions: Overdose
• Intervention / Treatment: Drug: Activated Charcoal; Drug: Activated Charcoal

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activated charcoal with cola	Drug: Activated Charcoal; Activated charcoal alone; Drug: Activated Charcoal; Activated charcoal mixed with cola
Active Comparator: Activated charcoal	Drug: Activated Charcoal; Activated charcoal alone; Drug: Activated Charcoal; Activated charcoal mixed with cola

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absorption of acetaminophen as indicated by area under the curve	240 minutes
Maximum concentration acetaminophen	240 minutes
Time to maximum concentration of acetaminophen	240 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Questionnaire: 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
Questionnaire: 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
Questionnaire: 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
Questionnaire: 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
Questionnaire: 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

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Estimated): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose; Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: 1783698-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes