Study Summary
This trial will compare the effectiveness of two different regimens for taking buprenorphine/naloxone to treat opioid addiction. One group will take increasing doses of the medication until they reach an effective level, while the other group will take a standard dose.
- Opioid Use Disorder
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 30, 90, and 365 days
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Buprenorphine/naloxone Microdosing
1 of 2
Buprenorphine/naloxone Standard Dosing
1 of 2
Active Control
658 Total Participants · 2 Treatment Groups
Primary Treatment: Buprenorphine/naloxone Microdosing · No Placebo Group · Phase 2 & 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Moe, Jessica, Fiona O'Sullivan, Corinne M. Hohl, Mary M. Doyle-Waters, Claire Ronsley, Raymond Cho, Qixin Liu, and Pouya Azar. 2021. “Short Communication: Systematic Review on Effectiveness of Micro-induction Approaches to Buprenorphine Initiation”. Addictive Behaviors. Elsevier BV. doi:10.1016/j.addbeh.2020.106740.
- Moe, Jessica, Katherin Badke, Megan Pratt, Raymond Y Cho, Pouya Azar, Heather Flemming, K. Anne Sutherland, et al.. 2020. “Microdosing and Standard‐dosing Take‐home Buprenorphine from the Emergency Department: A Feasibility Study”. Journal of the American College of Emergency Physicians Open. Wiley. doi:10.1002/emp2.12289.
- Moe, Jessica, Mary M. Doyle-Waters, Fiona O'Sullivan, Corinne M. Hohl, and Pouya Azar. 2020. “Effectiveness of Micro-induction Approaches to Buprenorphine Initiation: A Systematic Review Protocol”. Addictive Behaviors. Elsevier BV. doi:10.1016/j.addbeh.2020.106551.
- Jessica Moe 2021. "Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04893525.
Frequently Asked Questions
What conditions does Buprenorphine/naloxone Microdosing help alleviate?
"Buprenorphine/naloxone Microdosing is a medication used to treat opioids most often, but it can also serve as relief for conditions such as pruritus, pain, and septic shock." - Anonymous Online Contributor
Are there any other instances where Buprenorphine/naloxone have been microdosed for research purposes?
"At the moment, 60 clinical trials are researching Buprenorphine/naloxone Microdosing. 14 of these trials are in Phase 3. While most of the studies for Buprenorphine/naloxone Microdosing are located in White River Junction, Vermont, there are 243 locations operating studies for Buprenorphine/naloxone Microdosing." - Anonymous Online Contributor