Trial Outcomes & Findings for Utility of Olanzapine in the Treatment of Opioid Withdrawal in the ED (NCT NCT02643355)

Results Overview

Rescue Medication (additional medications given for symptoms) within 1 hour of medication administration

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

1 Hour

Results posted on

2019-07-10

Participant Flow

Patients were recruited in the ED only, by ED physicians

One patient signed consent but withdrew before randomization to drug (Explaining N=70 total)

Participant milestones

Participant milestones
Measure	Olanzapine Standard of Care Option 1 - Olanzapine	Clonidine Standard of Care Option 2 - Clonidine
Overall Study STARTED	34	35
Overall Study COMPLETED	33	30
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Olanzapine Standard of Care Option 1 - Olanzapine	Clonidine Standard of Care Option 2 - Clonidine
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	0	2

Baseline Characteristics

Utility of Olanzapine in the Treatment of Opioid Withdrawal in the ED

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olanzapine n=33 Participants Standard of Care Option 1 - Olanzapine	Standard of Care - Clonidine n=30 Participants Standard of Care Option 2 - Clonidine	Total n=63 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	34 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized African-American	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Native American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Hour

Population: Patients who received medication within 1 hour

Rescue Medication (additional medications given for symptoms) within 1 hour of medication administration

Outcome measures

Outcome measures
Measure	Olanzapine n=33 Participants Standard of Care Option 1 - Olanzapine	Clonidine n=30 Participants Standard of Care Option 2 - Clonidine
Number of Participants That Received Rescue Medication for Withdrawal Symptoms Within 1 Hour	9 Participants	19 Participants

SECONDARY outcome

Timeframe: At 1 hour

Population: Patients who had COWs score calculated at 1 hour

Opiate withdrawal scale score for all patients who received medication by one hour The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale, ranging from 0 to 48 (5- 12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal). This tool can be used to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The 11 items on the scale include scores rate the following symptoms: pulse rate, GI upset, sweating, tremor, restlessness, yawning, pupil size, anxiety, bone or joint aches, gooseflesh skin, runny nose.

Outcome measures

Outcome measures
Measure	Olanzapine n=31 Participants Standard of Care Option 1 - Olanzapine	Clonidine n=27 Participants Standard of Care Option 2 - Clonidine
Clinical Opiate Withdrawal Scale Score at 1 Hour Post Medication	5.3 units on a scale Standard Deviation 4.4	6.7 units on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: 2 hours

Population: Patients who had data available at 2 hours

Opiate withdrawal scale score for all patients who received medication by one hour The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale, ranging from 0 to 48 (5- 12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal). This tool can be used to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The 11 items on the scale include scores rate the following symptoms: pulse rate, GI upset, sweating, tremor, restlessness, yawning, pupil size, anxiety, bone or joint aches, gooseflesh skin, runny nose.

Outcome measures

Outcome measures
Measure	Olanzapine n=25 Participants Standard of Care Option 1 - Olanzapine	Clonidine n=22 Participants Standard of Care Option 2 - Clonidine
Clinical Opiate Withdrawal Scale Score at 2 Hours Post Medication	4.8 units on a scale Standard Deviation 4.9	3.7 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Time of Disposition (on average within 6 hours)

Population: Patients who had data available at the time of disposition

Opiate withdrawal scale score for all patients who received medication by one hour The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale, ranging from 0 to 48 (5- 12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal). This tool can be used to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The 11 items on the scale include scores rate the following symptoms: pulse rate, GI upset, sweating, tremor, restlessness, yawning, pupil size, anxiety, bone or joint aches, gooseflesh skin, runny nose.

Outcome measures

Outcome measures
Measure	Olanzapine n=14 Participants Standard of Care Option 1 - Olanzapine	Clonidine n=13 Participants Standard of Care Option 2 - Clonidine
Clinical Opiate Withdrawal Scale Score at the Time of Disposition	4.3 units on a scale Standard Deviation 3.3	3.6 units on a scale Standard Deviation 2.5

Adverse Events

Olanzapine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Clonidine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Olanzapine n=33 participants at risk Standard of Care Option 1 - Olanzapine	Clonidine n=30 participants at risk Standard of Care Option 2 - Clonidine
Nervous system disorders Dystonia	3.0% 1/33 • Number of events 1 • Adverse event data was collected for the duration of the ED encounter, on average within 6 hours AEs including hypotension (that resolved without treatment other than fluids), and extrapyramidal side effects are NOT CONSIDERED serious adverse events	0.00% 0/30 • Adverse event data was collected for the duration of the ED encounter, on average within 6 hours AEs including hypotension (that resolved without treatment other than fluids), and extrapyramidal side effects are NOT CONSIDERED serious adverse events
Nervous system disorders Akathisia	3.0% 1/33 • Number of events 1 • Adverse event data was collected for the duration of the ED encounter, on average within 6 hours AEs including hypotension (that resolved without treatment other than fluids), and extrapyramidal side effects are NOT CONSIDERED serious adverse events	0.00% 0/30 • Adverse event data was collected for the duration of the ED encounter, on average within 6 hours AEs including hypotension (that resolved without treatment other than fluids), and extrapyramidal side effects are NOT CONSIDERED serious adverse events
Cardiac disorders Hypotension	0.00% 0/33 • Adverse event data was collected for the duration of the ED encounter, on average within 6 hours AEs including hypotension (that resolved without treatment other than fluids), and extrapyramidal side effects are NOT CONSIDERED serious adverse events	3.3% 1/30 • Number of events 1 • Adverse event data was collected for the duration of the ED encounter, on average within 6 hours AEs including hypotension (that resolved without treatment other than fluids), and extrapyramidal side effects are NOT CONSIDERED serious adverse events

Additional Information

Dr. Marc Martel

Hennepin Healthcare

Phone: 612-873-7448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place