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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admission must be for an infection associated with intravenous drug use
Patient must be willing to speak with healthcare provider about MOUDs
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up12 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test whether an evidence-based method for making treatment decisions, called a "decision aid," can reduce stigma around opioid use disorder (OUD) and increase engagement in treatment among patients and providers in rural Missouri.
Eligible Conditions
- Opioid Use Disorder
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must have an infection caused by using drugs with a needle.
Select...
You must be open to talking with a healthcare provider about medications for opioid use disorder (MOUDs).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of recruitment/randomization
Acceptability of the intervention to patients
Contamination of arms for patients
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Shared Decision Making AidActive Control1 Intervention
Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute tablet- or web-based intervention administered by one of our wraparound care service team members in-person or via telehealth (or possibly in person depending on pandemic procedures). IT will be a 10-minute procedure with summary of decision considerations and patient value assessment.The provider will have access to then have access to this summary in making final care decisions with the patient.
Group II: Baseline Counseling As UsualActive Control1 Intervention
Patients randomized to the baseline counseling as usual arm will receive provision of one of 3 MAT options, prescription and referral to community providers; overdose prevention education and access to naloxone kits; harm reduction counseling (e.g safe injection practices, referral to PrEP); lab testing for HIV, HBV, HCV infection, and routine vaccinations (e.g. Hepatitis A). That includes wrap-around services modeled on the Ryan White Program, with access to social worker, case manager, and mental health counselor who follow up with patients, enroll them in insurance as eligible, and provide ongoing support. This will be a 10-minute tablet- or web-based intervention administered by one of our wraparound care service team members in-person or via telehealth (or possibly in person depending on pandemic procedures). IT will be a 10-minute procedure with summary of decision considerations and patient value assessment.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,900 Previous Clinical Trials
2,280,903 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,397 Previous Clinical Trials
2,060,384 Total Patients Enrolled
Michael J. Durkin, MDPrincipal InvestigatorWashington University School of Medicine
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an opportunity to join this clinical experiment?
"Per the clinicaltrials.gov website, this medical study is still seeking participants. It was first announced on April 7th 2022 and underwent its last update about 3 weeks later on April 26th of the same year."
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