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

NCT06219967 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1783698-11
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Overdose

Outcome Measures

Primary Outcomes (3)

• 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

• Maximum Concentration Acetaminophen

  Maximum concentration of acetaminophen (mcg/mL)

  240 minutes

• Time to Maximum Concentration of Acetaminophen

  Time of maximum concentration of acetaminophen (minutes)

  240 minutes

Secondary Outcomes (5)

• Appeal of Charcoal Mixture

  5 minutes

• Smell of Charcoal Mixture

  5 minutes

• Flavor of Charcoal Mixture

  5 minutes

• Texture of Charcoal Mixture

  5 minutes

• Overall Appeal of Charcoal Mixture

  5 minutes

Study Arms (2)

Activated charcoal with cola

EXPERIMENTAL

Drug: Activated Charcoal

Activated charcoal

ACTIVE COMPARATOR

Drug: Activated Charcoal

Interventions

Activated Charcoal DRUG

Activated charcoal alone

Activated charcoal

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

SUNY Upstate Medical University Clinical Research Unit

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Drug Overdose

Interventions

Charcoal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Results Point of Contact

• Title: Michael Keenan, MD
• Organization: SUNY Upstate Department of Emergency Medicine

keenanm@upstate.edu

315-416-4457

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Emergency Medicine

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 23, 2024
• Study Start: January 4, 2023
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)