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YORS for Opioid Use Disorder (YORS Trial)
N/A
Recruiting
Led By Marc Fishman, MD
Research Sponsored by Potomac Health Foundations
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: data measured every 2 weeks for the duration of the 26-week study period
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to find a more effective way to help young adults with opioid use disorder stay on their medication and in treatment, in order to improve public health outcomes related to the opioid crisis.
Who is the study for?
This trial is for young adults aged 18-28 with opioid use disorder who are willing to take relapse prevention medications and involve a family member or significant other in their treatment. It's not suitable for those living too far from the center, experiencing homelessness, or dealing with severe psychiatric or medical conditions.
What is being tested?
The YORS intervention is being tested to see if it helps young adults stick to their medication plans and stay engaged in treatment. The study includes refining the program through feedback and then testing its effectiveness compared to standard care.
What are the potential side effects?
Since this trial focuses on support interventions rather than medications, specific side effects aren't listed. However, participants may experience emotional or psychological impacts related to therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: data measured every 2 weeks for the duration of the 26-week study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: data measured every 2 weeks for the duration of the 26-week study period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of MOUD injections received (XR-NTX or XR-BUP)
Rate of opioid relapse during the study period
Awards & 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: Youth Opioid Recovery Support (YORS)Experimental Treatment1 Intervention
The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR-NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence.
The specific components of YORS will be refined and adapted based on feedback from interviews and focus groups with various stakeholders. However, the basic framework outlined above is expected to persists.
Group II: Treatment As UsualActive Control1 Intervention
TAU will contain patients who will be receiving treatment for opioid use disorder through their usual venues without the family engagement, assertive outreach, contingency management, and home delivery of medication. This often includes a referral and warm hand off to intensive outpatient SUD services and/or mental health care.
Find a Location
Who is running the clinical trial?
Friends Research Institute, Inc.OTHER
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22,085 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
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National Center for Complementary and Integrative Health (NCCIH)NIH
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to receive XR-NTX or XR-BUP treatment from a specialized doctor or nurse.I am willing to involve a family member or someone close in my treatment.I am between 18 and 28 years old.I do not have severe mental health issues or unstable medical conditions that would stop me from joining the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Youth Opioid Recovery Support (YORS)
- Group 2: Treatment As Usual
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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