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Completed

NCT Number: NCT06219967

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

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.

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Key information

Conditions

Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SUNY Upstate Medical University Clinical Research Unit

Syracuse, New York, 13210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activated Charcoal

Drug

Activated charcoal alone

Primary outcomes

  1. 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

  2. Maximum Concentration Acetaminophen

    Time frame: 240 minutes

    Maximum concentration of acetaminophen (mcg/mL)

  3. Time to Maximum Concentration of Acetaminophen

    Time frame: 240 minutes

    Time of maximum concentration of acetaminophen (minutes)

Secondary outcomes

  1. Appeal of Charcoal Mixture

    Time frame: 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

  2. Smell of Charcoal Mixture

    Time frame: 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

  3. Flavor of Charcoal Mixture

    Time frame: 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

  4. Texture of Charcoal Mixture

    Time frame: 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

  5. Overall Appeal of Charcoal Mixture

    Time frame: 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

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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