Opioid-use Disorder Clinical Trial
— STAROfficial title:
Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
Verified date | December 2023 |
Source | University of Vermont |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient at Emergency Department - Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual (DSM) 5 Exclusion Criteria: - Participating in alternate treatment program for opioid use disorder - Prisoner - Inability to communicate - Psychosis - Suicidality - History of Buprenorphine injection - Critical Illness |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Medical Center | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont | National Institute on Drug Abuse (NIDA), Substance Abuse and Mental Health Services Administration (SAMHSA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 1 week | 1 week | |
Primary | Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 3 months | 3 months | |
Primary | Number of Participants With Self-reported Treatment Retention | Self-reported enrollment in treatment for opioid use disorder after 6 months | 6 months | |
Secondary | 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. | 1 week | |
Secondary | 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. | 3 months | |
Secondary | 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. | 6 months |
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