Study Summary
This trial will compare two different types of care for people who are prescribed medication for opioid use disorder and who are released from detention facilities. 800 people will be followed for a year, and surveys and drug screenings will be used to track their progress.
Eligible Conditions
- Opioid Addiction
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 4 Secondary · Reporting Duration: 12 months following jail release
Month 12
Death
Overdose
Percent days of illicit opioid use
Retention on medication for OUD (MOUD)
Time to Overdose
Month 12
Therapeutic procedure
Retention in primary care
Day 30
Therapeutic procedure
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard Primary Care
1 of 2
Transitions Clinic Network Primary Care
1 of 2
Active Control
Experimental Treatment
800 Total Participants · 2 Treatment Groups
Primary Treatment: Transitions Clinic Network Primary Care · No Placebo Group · N/A
Transitions Clinic Network Primary Care
Behavioral
Experimental Group · 1 Intervention: Transitions Clinic Network Primary Care · Intervention Types: BehavioralStandard Primary Care
Behavioral
ActiveComparator Group · 1 Intervention: Standard Primary Care · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months following jail release
Who is running the clinical trial?
University of ConnecticutOTHER
162 Previous Clinical Trials
155,896 Total Patients Enrolled
University of RochesterOTHER
792 Previous Clinical Trials
501,084 Total Patients Enrolled
Albert Einstein College of MedicineOTHER
265 Previous Clinical Trials
1,838,466 Total Patients Enrolled
Hennepin Healthcare Research InstituteOTHER
84 Previous Clinical Trials
3,663,919 Total Patients Enrolled
Yale UniversityLead Sponsor
1,679 Previous Clinical Trials
21,087,023 Total Patients Enrolled
2 Trials studying Opioid Addiction
23 Patients Enrolled for Opioid Addiction
University of California, San FranciscoOTHER
2,283 Previous Clinical Trials
11,576,855 Total Patients Enrolled
University of Puerto RicoOTHER
49 Previous Clinical Trials
16,562 Total Patients Enrolled
University of MiamiOTHER
794 Previous Clinical Trials
384,104 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,247 Previous Clinical Trials
5,618,694 Total Patients Enrolled
4 Trials studying Opioid Addiction
265 Patients Enrolled for Opioid Addiction
University of North CarolinaOTHER
155 Previous Clinical Trials
1,435,082 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be at least 18 years old.
You must be fluent in both English and Spanish.
Who else is applying?
What state do they live in?
| Wisconsin | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Howell, Benjamin A., Lisa Puglisi, Katie Clark, Carmen Albizu-Garcia, Evan Ashkin, Tyler Booth, Lauren Brinkley-Rubinstein, et al.. 2021. “The Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN-PATHS): A Hybrid Type-1 Effectiveness Trial of Enhanced Primary Care to Improve Opioid Use Disorder Treatment Outcomes Following Release from Jail”. Journal of Substance Abuse Treatment. Elsevier BV. doi:10.1016/j.jsat.2021.108315.
- 2021. "Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04309565.
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Conditions
Cancer Related
Treatments