Clinical trial NCT04585399: Increasing MAT Engagement With Financial Incentives
Official title: Increasing MAT Engagement With Contingency Management Among Individuals With Opioid Use Disorder in an ED Bridge Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: The Cooper Health System
First posted: 2020-10-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group, randomized controlled trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Attendance at first scheduled clinic appointment
timeFrame: 1 week
measure: Percentage of sessions where buprenorphine positive urine results was recorded
timeFrame: 3-months
measure: Percentage of sessions where opioid free urine results were recorded
timeFrame: 3-months
measure: Treatment acceptability
timeFrame: 3-months
Secondary outcomes:
measure: Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results
timeFrame: 3-months
measure: Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results
timeFrame: 3-months
measure: Substance-free activities as a correlate of opioid-free urine test results and buprenorphine-positive results
timeFrame: 3-months
measure: Neurological Soft Signs correlate with treatment success
timeFrame: 3-months
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
References: