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

NCT02643355 | Completed Results DMC

• 1 other identifier: HSR# 15-4004
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Withdrawal Syndrome

Keywords

Narcotic Withdrawal; Opiate Withdrawal; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Received Rescue Medication for Withdrawal Symptoms Within 1 Hour

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

  1 Hour

Secondary Outcomes (3)

• Clinical Opiate Withdrawal Scale Score at 1 Hour Post Medication

  At 1 hour

• Clinical Opiate Withdrawal Scale Score at 2 Hours Post Medication

  2 hours

• Clinical Opiate Withdrawal Scale Score at the Time of Disposition

  Time of Disposition (on average within 6 hours)

Study Arms (2)

Standard of Care - Olanzapine

EXPERIMENTAL

Drug of interest in the study - Olanzapine

Drug: Olanzapine

Standard of Care - Clonidine

ACTIVE COMPARATOR

Standard of care - clonidine

Drug: Clonidine

Interventions

Olanzapine DRUG

Standard of Care - Olanzapine

Clonidine DRUG

Standard of Care - Clonidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age less than 18
• Allergy to either medication (olanzapine, clonidine)
• Inability to give informed consent
• Known pregnancy

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Emergencies

Interventions

Olanzapine; Clonidine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Marc Martel
• Organization: Hennepin Healthcare

Edresearch@hcmed.org

612-873-7448

Study Officials

• Marc Martel, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 31, 2015
• Study Start: November 1, 2015
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Locations

US (1)