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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Completed |
NCT03065049 -
Transforming Recovery Through Exercise and Community
|
N/A | |
Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Suspended |
NCT05001789 -
Cognitive Functioning in Opioid Use Disorder
|
N/A | |
Active, not recruiting |
NCT04650386 -
Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients
|
N/A | |
Completed |
NCT03715634 -
Study of a Novel Subcutaneous Depot Formulation of Buprenorphine
|
Phase 1 | |
Enrolling by invitation |
NCT04991974 -
Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
|
Phase 2/Phase 3 | |
Completed |
NCT04122755 -
Single Ascending Dose Study of ALA-1000
|
Phase 1 | |
Recruiting |
NCT05028998 -
COVID-19-Related Opioid Treatment Policy Evaluation
|
||
Recruiting |
NCT04927143 -
Encouraging Abstinence Behavior in a Drug Epidemic
|
Phase 2 | |
Recruiting |
NCT05049460 -
Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
|
N/A | |
Completed |
NCT05047627 -
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
|
N/A | |
Active, not recruiting |
NCT04129580 -
reSET-O RCT (Randomized Controlled Trial)
|
N/A | |
Recruiting |
NCT03923374 -
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
|
||
Completed |
NCT04464421 -
SMART Effectiveness Trial
|
N/A | |
Suspended |
NCT02687360 -
Imaging the Effects of rTMS on Chronic Pain
|
N/A | |
Completed |
NCT04056182 -
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
|
Phase 2 | |
Completed |
NCT03766893 -
Medication Maintenance Therapy in Community Pharmacy Settings
|
Early Phase 1 |