NCT03306368 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Fishman M, Wenzel K, Vo H, Wildberger J, Burgower R
A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Addiction. 2021 Mar;116(3):548-557. doi
Fishman MJ, Winstanley EL, Curran E, Garrett S, Subramaniam G
Treatment of opioid dependence in adolescents and young adults with extended release naltrexone: preliminary case-series and feasibility. Addiction. 2010 Sep;105(9):1669-76. doi: 10.1111/j.1360-0443.2010.03015.x. Epub 2010 Jul 9.
Vo HT, Burgower R, Rozenberg I, Fishman M
Home-based delivery of XR-NTX in youth with opioid addiction. J Subst Abuse Treat. 2018 Feb;85:84-89. doi: 10.1016/j.jsat.2017.08.007. Epub 2017 Aug 31.
Vo HT, Robbins E, Westwood M, Lezama D, Fishman M
Relapse prevention medications in community treatment for young adults with opioid addiction. Subst Abus. 2016 Jul-Sep;37(3):392-397. Epub 2016 Jan 28.
Wenzel K, Fishman M
Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. J Subst Abuse Treat. 2021 Jan;120:108149. doi: 10.1016/j.jsat.2020.108149. Epub 2020 Sep 24.
Wenzel K, Selby V, Wildberger J, Lavorato L, Thomas J, Fishman M
Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. J Subst Abuse Treat. 2021 Jun;125:108306. doi: 10.1016/j.jsat.2021.108306. Epub 2021 Jan 26.

Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone

Details for clinical trial NCT03306368

Clinical trial NCT03306368 - References