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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants at least 18 years of age
Be older than 18 years old
Must not have
Participants who demonstrate contraindication with Suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help patients with opioid use disorder who visit emergency departments. It uses a method where patients get rewards for sticking to their treatment plan, along with a medication that reduces cravings and withdrawal symptoms. The goal is to see if this combined approach helps more people start and continue their treatment compared to standard care.
Who is the study for?
This trial is for adults over 18 with Opioid Use Disorder who are new to the Bridge program at Cooper University ED and have a clinic appointment within a week. They must be in good health, not pregnant or breastfeeding, and able to give informed consent. Those with severe psychiatric conditions or on other opioid treatments can't join.
What is being tested?
The study tests if financial rewards (Contingency Management) help patients start and stick to treatment with buprenorphine + naloxone for Opioid Use Disorder in an emergency department setting compared to standard care without incentives.
What are the potential side effects?
While the trial focuses on Contingency Management rather than medication side effects, buprenorphine + naloxone may cause withdrawal symptoms, nausea, headache, dizziness, fatigue among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot use Suboxone or have used other medications for opioid addiction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Attendance at first scheduled clinic appointment
Percentage of sessions where buprenorphine positive urine results was recorded
Percentage of sessions where opioid free urine results were recorded
+1 moreSecondary study objectives
Delay discounting as a correlate of opioid-free urine test results and buprenorphine-positive results
Neurological Soft Signs correlate with treatment success
Opioid demand as a correlate of opioid-free urine test results and buprenorphine-positive results
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Contingency ManagementExperimental Treatment1 Intervention
Participants in this arm of the study will receive financial incentives for attending their buprenorphine appointments and for being clean from other opioids. Participants in this group will also have up to two rides per week paid for to attend bup appointments.
Group II: Standard CareActive Control1 Intervention
Participants in this group will be treatment as usual and will not receive any incentives for attending their bup appointments or for being opioid abstinent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contingency management
2006
Completed Phase 4
~1020
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Opioid Use Disorder (OUD) include buprenorphine, contingency management (CM), and the community reinforcement approach (CRA). Buprenorphine, a partial opioid agonist, helps reduce cravings and withdrawal symptoms by binding to opioid receptors in the brain without producing a high.
Contingency management uses positive reinforcement, such as vouchers or rewards, to encourage adherence to treatment and abstinence. The community reinforcement approach combines CM with other behavioral therapies to enhance life satisfaction and reduce substance use.
These treatments are essential for OUD patients as they address both the physiological and psychological aspects of addiction, promoting long-term recovery and reducing the risk of relapse.
Narcotics addiction treatment: behavioral methods concurrent with methadone maintenance.Contingency Management for Patients Receiving Medication for Opioid Use Disorder: A Systematic Review and Meta-analysis.Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence.
Narcotics addiction treatment: behavioral methods concurrent with methadone maintenance.Contingency Management for Patients Receiving Medication for Opioid Use Disorder: A Systematic Review and Meta-analysis.Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence.
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Who is running the clinical trial?
The Cooper Health SystemOTHER
80 Previous Clinical Trials
35,427 Total Patients Enrolled
Rowan UniversityLead Sponsor
24 Previous Clinical Trials
2,844 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who want to be in the Bridge program must be new enrollees, who have their first appointment at the Cooper Outreach Clinic within a week of enrollment.I am not pregnant, breastfeeding, or have a psychiatric condition like uncontrolled schizophrenia, bipolar disorder, or dementia.I cannot use Suboxone or have used other medications for opioid addiction.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Contingency Management
- Group 2: Standard Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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