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