Utility of Olanzapine in the Treatment of Opioid Withdrawal in the ED
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/8/2017 |
| Start Date: | November 2015 |
| End Date: | November 2017 |
| Contact: | Audrey Hendrickson, MPH |
| Email: | ED.Research.Associate.Program@hcmed.org |
Utility of Olanzapine in the Treatment of Opioid Withdrawal in the Emergency Department
Withdrawal from opioids is a clinical scenario that emergency department physicians encounter
frequently. Patients who present with opioid withdrawal display symptoms such as agitation,
anxiety, myalgias, abdominal pain, diarrhea, nausea, and vomiting. Currently, the standard
treatment for opioid withdrawal is clonidine (an alpha-2 adrenergic agonist), as well as
supportive cares (anti-emetics, intravenous fluids). Olanzapine is an atypical antipsychotic
that is given frequently in the ED for many of the same symptoms that are seen in patients
who are experiencing opioid withdrawal, however its use in this toxidrome has never been
studied. The hypothesis of this study is that olanzapine is a safe and efficacious option
when compared to clonidine for the treatment of opioid withdrawal in the emergency
department.
frequently. Patients who present with opioid withdrawal display symptoms such as agitation,
anxiety, myalgias, abdominal pain, diarrhea, nausea, and vomiting. Currently, the standard
treatment for opioid withdrawal is clonidine (an alpha-2 adrenergic agonist), as well as
supportive cares (anti-emetics, intravenous fluids). Olanzapine is an atypical antipsychotic
that is given frequently in the ED for many of the same symptoms that are seen in patients
who are experiencing opioid withdrawal, however its use in this toxidrome has never been
studied. The hypothesis of this study is that olanzapine is a safe and efficacious option
when compared to clonidine for the treatment of opioid withdrawal in the emergency
department.
This study will be a randomized control trial where patients will be randomized to receive
intramuscular olanzapine or oral clonidine as the first intervention given for treatment of
opiate withdrawal. This study will not be blinded.
Screening and enrollment: Research Associates will screen patients by review of the
electronic medical record. When these patients are identified, the RA will approach the CITI
trained ED provider who will obtain written informed consent. Allergies to either medication
will be screened for in Epic by the research associates. Allergies will also be verified by
the provider who is completing the consent.
Study protocol: If the patient consents to enroll in the study, the research associate will
randomize the patient to receive olanzapine or clonidine as the first treatment intervention.
The ED provider will then order that medication for the patient and will it be administered
by nursing staff. At this time the provider may order the patient to have a peripheral IV
placed and IV fluids administered at their discretion. No other supportive measures
(anti-emetics, non-narcotic pain medications) may be given at this time.
Prior to medication administration, the research associate will assess the patient's
withdrawal symptoms using the Clinical Opiate Withdrawal Scale for withdrawal symptoms. This
is a validated tool used to assess degree of withdrawal symptoms by evaluating physiologic
and symptomatic parameters. The medical provider will also obtain information regarding the
patients opioid use history (what type of opioid used, chronicity of use, date and time of
last use). After the study medication administration, patients will be observed for clinical
improvement. At 30 minutes, additional medications or interventions may be prescribed at the
discretion of the ED provider for symptom control, including crossover of the study
medications. The research associate will record which other medications/interventions were
ordered, the indication for these interventions, and times administered.
Symptoms will be re-assessed by the research associate using the COWS at 60 minutes, 120
minutes post administration of the initial treatment intervention, as well as at 4 hours post
administration (approximately time of discharge from the emergency depatment). At these same
time marks, sedation of the patient will be assessed using the overt agitation severity scale
(OASS). Throughout the patient's ED stay, the research associate will be monitoring for
adverse complications such as allergic reaction, dystonia, akathisia, respiratory
complications, or hypotension.
The investigators will conduct preliminary data analysis after the first 25 and 50 patients
are enrolled, respectively. Initial power analysis and sample size calculations delineated
that the investigators would need 35 patients per arm to detect a 50% difference in the need
for rescue medication at 1 hour between the two study medications.
intramuscular olanzapine or oral clonidine as the first intervention given for treatment of
opiate withdrawal. This study will not be blinded.
Screening and enrollment: Research Associates will screen patients by review of the
electronic medical record. When these patients are identified, the RA will approach the CITI
trained ED provider who will obtain written informed consent. Allergies to either medication
will be screened for in Epic by the research associates. Allergies will also be verified by
the provider who is completing the consent.
Study protocol: If the patient consents to enroll in the study, the research associate will
randomize the patient to receive olanzapine or clonidine as the first treatment intervention.
The ED provider will then order that medication for the patient and will it be administered
by nursing staff. At this time the provider may order the patient to have a peripheral IV
placed and IV fluids administered at their discretion. No other supportive measures
(anti-emetics, non-narcotic pain medications) may be given at this time.
Prior to medication administration, the research associate will assess the patient's
withdrawal symptoms using the Clinical Opiate Withdrawal Scale for withdrawal symptoms. This
is a validated tool used to assess degree of withdrawal symptoms by evaluating physiologic
and symptomatic parameters. The medical provider will also obtain information regarding the
patients opioid use history (what type of opioid used, chronicity of use, date and time of
last use). After the study medication administration, patients will be observed for clinical
improvement. At 30 minutes, additional medications or interventions may be prescribed at the
discretion of the ED provider for symptom control, including crossover of the study
medications. The research associate will record which other medications/interventions were
ordered, the indication for these interventions, and times administered.
Symptoms will be re-assessed by the research associate using the COWS at 60 minutes, 120
minutes post administration of the initial treatment intervention, as well as at 4 hours post
administration (approximately time of discharge from the emergency depatment). At these same
time marks, sedation of the patient will be assessed using the overt agitation severity scale
(OASS). Throughout the patient's ED stay, the research associate will be monitoring for
adverse complications such as allergic reaction, dystonia, akathisia, respiratory
complications, or hypotension.
The investigators will conduct preliminary data analysis after the first 25 and 50 patients
are enrolled, respectively. Initial power analysis and sample size calculations delineated
that the investigators would need 35 patients per arm to detect a 50% difference in the need
for rescue medication at 1 hour between the two study medications.
Inclusion Criteria:
- Any patients who present to the emergency department where the providers are concerned
for opioid withdrawal contributing to their symptoms on presentation is eligible for
inclusion.
Exclusion Criteria:
- Age less than 18
- Allergy to either medication (olanzapine, clonidine)
- Inability to give informed consent
- Known pregnancy
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