Opioid-use Disorder
Conditions
Brief summary
The increased prevalence of opioid use disorder (OUD) and associated overdoses and adverse events has led to a substantial increase in the number of patients being seen at emergency departments (ED). Thus, the ED may be an ideal location for identifying patients in need of OUD treatment and can serve as the first touch point in the OUD continuum of care to promote medication assisted treatment initiation. Contingency management (CM) is an effective method for promoting treatment initiation and adherence that has not been thoroughly evaluated for this purpose. The primary aim of the current study is to develop and assess the effectiveness, acceptability, and feasibility of a protocol for delivering CM to increase combined buprenorphine + nalaxone (referred to as BUP hereafter) initiation and continuous adherence for OUD in an existing ED bridge program (e.g., Bridge plus CM; B+CM) relative to standard care. Secondary objectives include identifying behavioral and neuropsychological correlates to treatment outcomes, including delay discounting, reinforcer demand, and neurological soft signs.
Interventions
BEHAVIORALContingency management
Financial incentives for attending bup appointments and demonstrating opioid abstinence. Rides will also be provided for up to two clinic visits per week.
Sponsors
The Cooper Health System
Rowan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Participants will only told if they are assigned to the contingency management group because there are different procedures for those individuals. The care providers will not know which participants are in the control group but they may know when people are in the CM group because extra urine screens will be collected and they will be scheduled for rides.
Intervention model description
Two group, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants at least 18 years of age 2. Participants must be newly enrolled in the Bridge program in the Cooper University ED, with their first clinic appointment scheduled to take place at the Cooper Outreach Clinic within one week of enrollment. 3. All subjects must be in good physical health as determined by a physical examination and premenopausal women will have a pregnancy test on the day of the study to rule out pregnancy
Exclusion criteria
1. Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder. 2. Participants who are currently pregnant or breastfeeding or have been diagnosed with a DSM-5 psychiatric condition that might interfere with treatment delivery (e.g., uncontrolled schizophrenia, bipolar disorder, dementia) 3. Participants who are non-English speaking or cannot otherwise provide valid informed consent. 4. Individuals who are unable to complete the survey assessments, due to literacy or visual impairments. 5. The participant will not be a prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment acceptability | 3-months | Participants will evaluate the treatment at the end. |
| Attendance at first scheduled clinic appointment | 1 week | We will track attendance at participant's first scheduled BUP appointment after being bridged from the ED |
| Percentage of sessions where buprenorphine positive urine results was recorded | 3-months | Urine-verified buprenorphine |
| Percentage of sessions where opioid free urine results were recorded | 3-months | Urine-verified opioid abstinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results | 3-months | A modified Pleasant Events Scale survey will be used to evaluate access to, and enjoyment from, substance-free activities and the results will be correlated with urine results determining opioid abstinence and buprenorphine adherence. |
| Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results | 3-months | Delay discounting will be evaluated, using the brief, five question delay discounting procedure and will be correlated with urine results determining opioid abstinence and buprenorphine adherence. |
| Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results | 3-months | The opioid purchasing task will be used to evaluate opioid demand and will be correlated with urine results determining opioid abstinence and buprenorphine adherence. |
| Neurological Soft Signs correlate with treatment success | 3-months | Participants will complete a drawing task that has been correlated with other substance use treatment outcomes in the past. |
Countries
United States
Outcome results
None listed