Mental Disorder, Opioid Medication Assisted Treatment, Opioid-use Disorder
Conditions
Brief 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.
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.
Interventions
OTHERBridge Clinic
Specialized addiction bridge clinic
Sponsors
Substance Abuse and Mental Health Services Administration (SAMHSA)
National Institute on Drug Abuse (NIDA)
University of Vermont
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported Treatment Retention | 1 week | Self-reported enrollment in treatment for opioid use disorder after 1 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Illicit Opioid Use | 1 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bridge Clinic Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
Bridge Clinic: Specialized addiction bridge clinic | 94 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 1 Week Contacted for Self-report | Lost to Follow-up | 27 |
| 1 Week Eligible for Urinanalysis | COVID disruption of urine sampling | 52 |
| 1 Week Eligible for Urinanalysis | Incarcerated/Institutionalized | 1 |
| 1 Week Eligible to Self-report | Incarcerated/Institutionalized | 1 |
| 1 Week Urine Sample Provided | Lost to Follow-up | 13 |
| 3 Months Contacted for Self-report | Lost to Follow-up | 22 |
| 3 Months Eligible for Urinanalysis | COVID disruption of urine sampling | 70 |
| 3 Months Eligible to Self-report | Incarcerated/Institutionalized | 7 |
| 3 Months Urine Sample Provided | Lost to Follow-up | 13 |
| 6 Months Contacted for Self-report | Lost to Follow-up | 17 |
| 6 Months Eligible for Urinanalysis | COVID disruption of urine sampling | 91 |
| 6 Months Eligible to Self-report | Incarcerated/Institutionalized | 9 |
| Baseline | Protocol Violation | 10 |
Baseline characteristics
| Characteristic | Bridge Clinic |
|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 8.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Region of Enrollment United States | 94 participants |
| Sex/Gender, Customized Male/Female/Unknown Female | 33 Participants |
| Sex/Gender, Customized Male/Female/Unknown Male | 60 Participants |
| Sex/Gender, Customized Male/Female/Unknown Unknown | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 94 |
| other Total, other adverse events | 0 / 94 |
| serious Total, serious adverse events | 0 / 94 |
Outcome results
Primary
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 1 week
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bridge Clinic | Number of Participants With Self-reported Treatment Retention | 51 Participants |
Primary
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 3 months
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bridge Clinic | Number of Participants With Self-reported Treatment Retention | 49 Participants |
Primary
Number of Participants With Self-reported Treatment Retention
Self-reported enrollment in treatment for opioid use disorder after 6 months
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bridge Clinic | Number of Participants With Self-reported Treatment Retention | 51 Participants |
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.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bridge Clinic | Number of Participants With Illicit Opioid Use | 20 Participants |
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.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bridge Clinic | Number of Participants With Illicit Opioid Use | 14 Participants |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bridge Clinic | Number of Participants With Illicit Opioid Use | 1 Participants |