Trial Outcomes & Findings for Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy (NCT NCT06219967)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

240 minutes

Results posted on

2024-05-30

Participant Flow

5 participants were screened for eligibility between January 4, 2023 and February 27, 2023.

All 5 screened participants met criteria for involvement in the study. Participants were randomized to receive either the charcoal or charcoal-cola mixture first, then, after at least 7 days between each session, the participants returned to complete the other arm of the study.

Participant milestones

Participant milestones
Measure	Activated Charcoal With Cola First, Then Activated Charcoal Alone Participants in this arm conducted the protocol with 50 g activated charcoal mixed with 240 mL of cola on study day 1. After a minimum of a 7 day washout period, they returned and repeated the protocol with 50 g activated charcoal alone.	Activated Charcoal Alone First, Then Activated Charcoal With Cola Participants in this arm conducted the protocol with 50 g activated charcoal alone on study day 1. After a minimum of a 7 day washout period, they returned and repeated the protocol with 50 g activated charcoal mixed with 240 mL of cola.
Study Day 1 STARTED	3	2
Study Day 1 COMPLETED	3	2
Study Day 1 NOT COMPLETED	0	0
Washout (at Least 7 Days) STARTED	3	2
Washout (at Least 7 Days) COMPLETED	3	2
Washout (at Least 7 Days) NOT COMPLETED	0	0
Study Day 2 STARTED	3	2
Study Day 2 COMPLETED	3	2
Study Day 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Activated Charcoal With Cola First n=3 Participants Participants received activated charcoal mixed with cola, then received activated charcoal alone	Activated Charcoal Alone First n=2 Participants Participants received activated charcoal alone, then received activated charcoal mixed with cola	Total n=5 Participants Total of all reporting groups
Age, Continuous	34 years n=5 Participants	29 years n=7 Participants	32 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Absorption of Acetaminophen as Indicated by Area Under the Curve	3566 mcg*min/mL Interval 1390.0 to 5742.0	3335 mcg*min/mL Interval 2573.0 to 4098.0

PRIMARY outcome

Timeframe: 240 minutes

Maximum concentration of acetaminophen (mcg/mL)

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Maximum Concentration Acetaminophen	33 mcg/mL Interval 7.0 to 59.0	29 mcg/mL Interval 20.0 to 37.0

PRIMARY outcome

Timeframe: 240 minutes

Time of maximum concentration of acetaminophen (minutes)

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Time to Maximum Concentration of Acetaminophen	51 minutes Interval 30.0 to 72.0	66 minutes Interval 56.0 to 76.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Appeal of Charcoal Mixture	4.6 score on a scale Interval 3.5 to 5.7	2.8 score on a scale Interval 1.0 to 4.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Smell of Charcoal Mixture	5.8 units on a scale Interval 2.7 to 8.9	6.4 units on a scale Interval 3.0 to 9.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Flavor of Charcoal Mixture	5.8 score on a scale Interval 4.2 to 7.4	3.0 score on a scale Interval 0.0 to 6.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Texture of Charcoal Mixture	4.4 score on a scale Interval 2.3 to 6.5	2.8 score on a scale Interval 1.2 to 4.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Activated Charcoal With Cola n=5 Participants Activated charcoal mixed with cola	Activated Charcoal Without Cola n=5 Participants Activated charcoal without cola (charcoal by itself)
Overall Appeal of Charcoal Mixture	4.4 score on a scale Interval 3.7 to 5.1	3.2 score on a scale Interval 0.0 to 6.4

Adverse Events

Activated Charcoal With Cola

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Activated Charcoal Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Keenan, MD

SUNY Upstate Department of Emergency Medicine

Phone: 315-416-4457

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place