Opioid-use DisorderSTARNCT04505540
Start Treatment and Recovery for Opioid Use Disorder
A study testing Bridge Clinic in people with Opioid-use Disorder and Mental Disorder, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Mental Disorder, Opioid Medication Assisted Treatment
- What is being tested?
- Bridge Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 31 Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at Emergency Department
- Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual (DSM) 5
Who cannot join
- Participating in alternate treatment program for opioid use disorder
- Prisoner
- Inability to communicate
- Psychosis
- Suicidality
- History of Buprenorphine injection
- Critical Illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.
Read the detailed description
The emergency department is a critical missed opportunity to engage patients with opioid use disorder in medication-assisted treatment, the most effective current treatment for the disorder. Patients presenting at the emergency department with opioid use disorder will be given the opportunity to immediately start medication assisted treatment with Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a local waivered provider for further treatment.
- Being tested
- Bridge Clinic
- Medical subject headings
- Opioid-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridge ClinicOther
Specialized addiction bridge clinic
| Study group | Role | What they receive |
|---|---|---|
| Bridge Clinic | Experimental | Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment. Receives: Other: Bridge Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 1 week
Measured: 1 week
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 3 months
Measured: 3 months
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 6 months
Measured: 6 months
Secondary outcomes (3)
Number of Participants With Illicit Opioid Use
Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.
Measured: 1 week
Number of Participants With Illicit Opioid Use
Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.
Measured: 3 months
Number of Participants With Illicit Opioid Use
Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start30 Sep 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 Opioid-use DisorderStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Scott Mackey, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505540
- Sponsor's protocol ID
- CHRMS: 18-0695
- Other IDs
- 1R21DA049859-01
- Acronym
- STAR
- Status last verified
- Dec 2023
- First submitted
- 11 Jun 2020
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04505540
- Acronym / sponsor ID
- STAR / CHRMS: 18-0695
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), National Institute on Drug Abuse (NIDA)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.
Detailed description
The emergency department is a critical missed opportunity to engage patients with opioid use disorder in medication-assisted treatment, the most effective current treatment for the disorder. Patients presenting at the emergency department with opioid use disorder will be given the opportunity to immediately start medication assisted treatment with Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a local waivered provider for further treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bridge Clinic | Experimental | Other: Bridge ClinicMedication assisted treatment supervised by addiction bridge clinic until stabilized in treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient at Emergency Department
- Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual (DSM) 5
Key exclusion criteria (7 listed)
- Participating in alternate treatment program for opioid use disorder
- Prisoner
- Inability to communicate
- Psychosis
- Suicidality
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 |
|---|---|---|
| Bridge ClinicSpecialized addiction bridge clinic | Other | Bridge Clinic |
Primary outcome
Number of Participants With Self-reported Treatment Retention
Time frame: 1 week
Self-reported enrollment in treatment for opioid use disorder after 1 week
Number of Participants With Self-reported Treatment Retention
Time frame: 3 months
Self-reported enrollment in treatment for opioid use disorder after 3 months
Number of Participants With Self-reported Treatment Retention
Time frame: 6 months
Self-reported enrollment in treatment for opioid use disorder after 6 months
3 secondary outcomes
Number of Participants With Illicit Opioid Use
Time frame: 1 week
Number of Participants With Illicit Opioid Use
Time frame: 3 months
Number of Participants With Illicit Opioid Use
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridge Clinic in people with Opioid-use Disorder and Mental Disorder, run by University of Vermont 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 2 inclusion and 7 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 11 Dec 2023. 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 11 Dec 2023). 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 With Self-reported Treatment Retention (time frame: 1 week). The study lists 3 primary outcomes in all. 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 11 Dec 2023.