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

NCT ID: NCT06219967

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2023-03-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Activated charcoal with cola

Group Type: EXPERIMENTAL

Activated Charcoal

Intervention Type: DRUG

Activated charcoal mixed with cola

Activated charcoal

Group Type: ACTIVE_COMPARATOR

Activated Charcoal

Intervention Type: DRUG

Activated charcoal alone

Interventions

Activated Charcoal

Activated charcoal alone

Intervention Type: DRUG

Activated Charcoal

Activated charcoal mixed with cola

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Michael Keenan

Assistant Professor Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SUNY Upstate Medical University Clinical Research Unit

Syracuse, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1783698-11

Identifier Type: -

Identifier Source: org_study_id