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17 News |  |
- | naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes
Trial withdrawal: Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone (clinicaltrials.gov) - Sep 23, 2021
P=N/A, N=0, Withdrawn, Sponsor: The Cleveland Clinic
Completed --> Withdrawn
- ||| naltrexone / Generic mfg.
Clinical, P3 data, Retrospective data, Journal: Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial. (Pubmed Central) - May 15, 2021
Improvements in most cognitive domains were associated with the transition from BUP to XR-NTX, particularly in participants entering the study on low-dose (<8 mg/day) BUP. These improvements may be due to the discontinuation of BUP, the treatment with XR-NTX, or both.
- | naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes
Trial completion: Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone (clinicaltrials.gov) - Feb 10, 2021
P=N/A, N=1, Completed, Sponsor: The Cleveland Clinic
These improvements may be due to the discontinuation of BUP, the treatment with XR-NTX, or both. Recruiting --> Completed
- || Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Clinical, Journal: Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended-Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens. (Pubmed Central) - Dec 30, 2020
The overall rate of successful induction across treatment groups supports a brief BUP taper with standing ancillary medications as a well-tolerated approach for patients seeking transition from BUP to XR-NTX. (Am J Addict 2020;00:00-00).
- | naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes
Trial completion date, Trial primary completion date: Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone (clinicaltrials.gov) - Mar 5, 2020
P=N/A, N=6, Recruiting, Sponsor: The Cleveland Clinic
(Am J Addict 2020;00:00-00). Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Oct 2019 --> Oct 2020
- | Zubsolv (buprenorphine/naloxone sublingual tablet) / Orexo, Mundipharma, Suboxone (buprenorphine/naloxone sublingual film) / Indivior
Clinical, Journal: Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. (Pubmed Central) - Oct 18, 2019
In the Cox proportional hazard model, use of injectable naltrexone, oral naltrexone, sublingual buprenorphine, and transdermal buprenorphine were all associated with significantly greater hazard of discontinuing therapy beginning >30days after MOUD initiation (HR=2.17, 2.54, 1.15, and 2.21, respectively, 95% CIs 2.04-2.30, 2.45-2.64, 1.10-1.19, and 2.11-2.33), compared with the use of sublingual or oralmucosal buprenorphine/naloxone...The proportion treated with injectable naltrexone, oral naltrexone, and transdermal buprenorphine grew over time but remains small, and the discontinuation rates are higher among those treated with these medications compared with those treated with sublingual or oralmucosal buprenorphine/naloxone. In the face of the opioid overdose and addiction crisis, new efforts are needed at the provider, health system, and policy levels so that MOUD availability and uptake keep pace with new OUD diagnoses and OUD treatment discontinuation is minimized.
- | naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes
New trial: Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone (clinicaltrials.gov) - Dec 4, 2018
P=N/A, N=6, Recruiting, Sponsor: The Cleveland Clinic
- ||||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Trial completion: Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL (clinicaltrials.gov) - Dec 27, 2017
P3, N=101, Completed, Sponsor: Alkermes, Inc.
In the face of the opioid overdose and addiction crisis, new efforts are needed at the provider, health system, and policy levels so that MOUD availability and uptake keep pace with new OUD diagnoses and OUD treatment discontinuation is minimized. Active, not recruiting --> Completed
- ||||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Trial completion: Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL (clinicaltrials.gov) - Feb 15, 2017
P3, N=380, Completed, Sponsor: Alkermes, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Enrollment open, Trial primary completion date: Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL (clinicaltrials.gov) - Dec 22, 2016
P3, N=92, Recruiting, Sponsor: Alkermes, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Recruiting | Trial primary completion date: May 2017 --> Nov 2017
- ||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Enrollment closed: Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL (clinicaltrials.gov) - Dec 22, 2016
P3, N=380, Active, not recruiting, Sponsor: Alkermes, Inc.
Active, not recruiting --> Recruiting | Trial primary completion date: May 2017 --> Nov 2017 Recruiting --> Active, not recruiting
- ||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Enrollment closed: Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL (clinicaltrials.gov) - Sep 14, 2016
P3, N=92, Active, not recruiting, Sponsor: Alkermes, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Enrollment open: Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL (clinicaltrials.gov) - May 3, 2016
P3, N=92, Recruiting, Sponsor: Alkermes, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
New P3 trial: Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL (clinicaltrials.gov) - Mar 2, 2016
P3, N=92, Not yet recruiting, Sponsor: Alkermes, Inc.
- |||||||||| naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
New P3 trial: Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL (clinicaltrials.gov) - Sep 1, 2015
P3, N=300, Recruiting, Sponsor: Alkermes, Inc.