Opioid WithdrawalPhase 4BEDNCT03174067
Buprenorphine in the Emergency Department
A Phase 4 study testing Buprenorphine and Clonidine in people with Opioid Withdrawal and Opioid-use Disorder, run by St. Joseph's Health Centre Toronto.
Trial summary
This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Opioid Withdrawal, Opioid-use Disorder
- What is being tested?
- Buprenorphine and Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presenting to the ED in opioid withdrawal or soon to be in withdrawal
- Minimum age 16
- English speaking
- Active phone number
- Ontario Health Insurance Program card
Who cannot join
- Pregnant
- Currently enrolled in a methadone or buprenorphine maintenance
- Benzodiazepine addiction (or taking >50mg of valium equivalent/day)
- Acute hepatitis or liver failure
About this study
Official title: Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal
This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid access addiction medicine clinic within a few days of emergency room presentation. Secondary treatment outcome is treatment status with respect to opioid agonist treatment at one month post emergency room visit.
- Conditions
- Opioid Withdrawal, Opioid-use Disorder
- Being tested
- Buprenorphine, Clonidine
- Keywords
- buprenorphine, emergency department
- Medical subject headings
- Opioid-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
The participant receives buprenorphine
ClonidineDrug
The participant receives clonidine
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine Receives: Drug: Buprenorphine |
| Clonidine | Active comparator | Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants attending the rapid access clinic
The number of participants who attend a rapid access clinic assessment after initial enrollment
Measured: 2-5 days
Secondary outcomes (1)
Number of participants who are on opioid agonist treatment
The number of participants who are maintained on some form of opioid agonist treatment at the one-month mark
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startMar 2013
- Primary completionApr 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid WithdrawalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Health Centre Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Srivastava, St. Joseph's Health Centre Toronto
- Investigators
- Anita Srivastava, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174067
- Sponsor's protocol ID
- BED2013
- Acronym
- BED
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srivastava A, Kahan M, Njoroge I, Sommer LZ. Buprenorphine in the emergency department: Randomized clinical controlled trial of clonidine versus buprenorphine for the treatment of opioid withdrawal. Can Fam Physician. 2019 May;65(5):e214-e220.
PubMed 31088887
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal
- ClinicalTrials.gov ID
- NCT03174067
- Acronym / sponsor ID
- BED / BED2013
- Conditions
- Opioid Withdrawal, Opioid-use Disorder
- Keywords
- buprenorphine, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St. Joseph's Health Centre TorontoUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid access addiction medicine clinic within a few days of emergency room presentation. Secondary treatment outcome is treatment status with respect to opioid agonist treatment at one month post emergency room visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: BuprenorphinePatient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine |
| Clonidine | Active comparator | Drug: ClonidinePatient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Presenting to the ED in opioid withdrawal or soon to be in withdrawal
- Minimum age 16
- English speaking
- Active phone number
- Ontario Health Insurance Program card
Key exclusion criteria (4 listed)
- Pregnant
- Currently enrolled in a methadone or buprenorphine maintenance
- Benzodiazepine addiction (or taking >50mg of valium equivalent/day)
- Acute hepatitis or liver failure
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 |
|---|---|---|
| BuprenorphineThe participant receives buprenorphine | Drug | Buprenorphine |
| ClonidineThe participant receives clonidine | Drug | Clonidine |
Primary outcome
Number of participants attending the rapid access clinic
Time frame: 2-5 days
The number of participants who attend a rapid access clinic assessment after initial enrollment
1 secondary outcome
Number of participants who are on opioid agonist treatment
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Derived from this study: PubMed 31088887Srivastava A, Kahan M, Njoroge I, Sommer LZ. Buprenorphine in the emergency department: Randomized clinical controlled trial of clonidine versus buprenorphine for the treatment of opioid withdrawal. Can Fam Physician. 2019 May;65(5):e214-e220.
- Individual participant dataSharing planned: No
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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.
Anita Srivastava, MD principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine and Clonidine in people with Opioid Withdrawal and Opioid-use Disorder, run by St. Joseph's Health Centre Toronto.
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 5 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 attending the rapid access clinic (time frame: 2-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174067, which also lists 1 linked publication.
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 2 Jun 2017.