Substance Withdrawal SyndromeNCT02643355
Utility of Olanzapine in the Treatment of Opioid Withdrawal in the ED
A study testing Olanzapine and Clonidine in people with Substance Withdrawal Syndrome, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- Olanzapine and Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 21 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age less than 18
- Allergy to either medication (olanzapine, clonidine)
- Inability to give informed consent
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Substance Withdrawal Syndrome
- Being tested
- Olanzapine, Clonidine
- Keywords
- Narcotic Withdrawal, Opiate Withdrawal, Emergency Department
- Medical subject headings
- Substance Withdrawal Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
ClonidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care - Olanzapine | Experimental | Drug of interest in the study - Olanzapine Receives: Drug: Olanzapine |
| Standard of Care - Clonidine | Active comparator | Standard of care - clonidine Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Hour
Secondary outcomes (3)
Clinical Opiate Withdrawal Scale Score at 1 Hour Post Medication
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.
Measured: At 1 hour
Clinical Opiate Withdrawal Scale Score at 2 Hours Post Medication
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.
Measured: 2 hours
Clinical Opiate Withdrawal Scale Score 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.
Measured: Time of Disposition (on average within 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Martel, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643355
- Sponsor's protocol ID
- HSR# 15-4004
- Status last verified
- Jun 2019
- First submitted
- 17 Dec 2015
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Olanzapine in the Treatment of Opioid Withdrawal in the Emergency Department
- ClinicalTrials.gov ID
- NCT02643355
- Acronym / sponsor ID
- HSR# 15-4004
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- Narcotic Withdrawal, Opiate Withdrawal, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care - Olanzapine | Experimental | Drug: OlanzapineDrug of interest in the study - Olanzapine |
| Standard of Care - Clonidine | Active comparator | Drug: ClonidineStandard of care - clonidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Age less than 18
- Allergy to either medication (olanzapine, clonidine)
- Inability to give informed consent
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine | Drug | Standard of Care - Olanzapine |
| Clonidine | Drug | Standard of Care - Clonidine |
Primary outcome
Number of Participants That Received Rescue Medication for Withdrawal Symptoms Within 1 Hour
Time frame: 1 Hour
Rescue Medication (additional medications given for symptoms) within 1 hour of medication administration
3 secondary outcomes
Clinical Opiate Withdrawal Scale Score at 1 Hour Post Medication
Time frame: At 1 hour
Clinical Opiate Withdrawal Scale Score at 2 Hours Post Medication
Time frame: 2 hours
Clinical Opiate Withdrawal Scale Score at the Time of Disposition
Time frame: Time of Disposition (on average within 6 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Martel, MD principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olanzapine and Clonidine in people with Substance Withdrawal Syndrome, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Received Rescue Medication for Withdrawal Symptoms Within 1 Hour (time frame: 1 Hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.