naltrexone oral/buprenorphine sublingual (ALKS 6428 transition kit) / Alkermes - LARVOL DELTA

Baseline Moderators of Response to Naltrexone and Bupropion in the Treatment of Methamphetamine Use Disorder: An ADAPT-2 Study. (PubMed, J Addict Med) - "This is a proof-of-concept analysis that needs to establish generalizability. This classification rule could help improve treatment selection, clinicians' treatment decisions, and patient outcomes."

Journal

Craving, Impulsivity, and Subsequent Methamphetamine Use With Naltrexone-Bupropion Versus Placebo: Findings From a Randomized Clinical Trial. (PubMed, J Addict Med) - "Further investigations are necessary to optimize NTX-BUP treatment, focusing on the impact of craving and impulsivity on outcomes."

Clinical • Journal

Exploring the Impact of Reduction in Methamphetamine Use on Sexual Risk Behaviors Among Men Who Have Sex with Men and Women: Findings from the ADAPT- 2 Trial. (PubMed, Int J Behav Med) - "Our analysis showed that reductions in MA use was associated with reductions in several sexual risk behaviors associated with HIV/STI. These findings provide further support for exploring reductions in sexual risk behaviors as a clinical endpoint in future treatment interventions for MA use."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease

Racial and Ethnic Differences in Patients Reported Outcomes Among Participants in a Randomized Controlled Trial of Extended-Release Naltrexone and Bupropion for Methamphetamine Use Disorder (CPDD 2024) - "Financial Support : NIDA ( grant# K01DA047918) Aim: The aim of this secondary analysis was to explore racial and ethnic differences in baseline sociodemographic and clinical characteristics as well as treatment effects on a measure of substance use recovery, depression symptoms, and methamphetamine craving among participants in a pharmacotherapy trial for methamphetamine use disorder : The ADAPT-2 trial was a multisite, 12-week randomized, double-blind, trial that employed a two-stage sequential parallel design to evaluate the efficacy of combination naltrexone (NTX) and oral bupropion (BUP) vs. placebo for Meth UD. Although we found racial and ethnic differences at baseline, our findings did not show racial and ethnic differences in treatment effects of NTX-BUP on recovery, depression symptoms and methamphetamine cravings. However, our findings also highlight the need to expand representation of racial and ethnic minority groups in future trials."

Clinical • CNS Disorders • Depression • Psychiatry

Sociodemographic and patient reported outcomes by racial and ethnicity status among participants in a randomized controlled trial for methamphetamine use disorder. (PubMed, Drug Alcohol Depend Rep) - P3 | "The ADAPT-2 trial (ClinicalTrials.gov number, NCT03078075; N=403; 69% male) was a multisite, 12-week randomized, double-blind, trial that employed a two-stage sequential parallel design to evaluate the efficacy of combination naltrexone (NTX) and oral bupropion (BUP) vs. placebo for Meth UD. Although we found racial and ethnic differences at baseline, our findings did not show racial and ethnic differences in treatment effects of NTX-BUP on recovery, depression symptoms and methamphetamine cravings. However, our findings also highlight the need to expand representation of racial and ethnic minority groups in future trials."

Clinical • Journal • Patient reported outcomes • CNS Disorders • Depression • Psychiatry

Naltrexone plus bupropion reduces cigarette smoking in individuals with methamphetamine use disorder: A secondary analysis from the CTN ADAPT-2 trial. (PubMed, J Subst Use Addict Treat) - "NTX-BUP was associated with significant reductions in self-reported cigarette smoking in the context of concurrent treatment for MA use disorder. These off-target medication effects warrant prospective investigation using biochemically confirmed measures of smoking abstinence. The development of NTX-BUP as a co-addiction treatment strategy has a potential for high public health impact."

Journal • CNS Disorders • Psychiatry • Tobacco Cessation

Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone (clinicaltrials.gov) - P=N/A; N=1; Completed; Sponsor: The Cleveland Clinic; Recruiting ➔ Completed

Clinical • Trial completion • Substance Abuse

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, Addict Behav) - "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."

Clinical • Journal • P3 data • Retrospective data • Addiction (Opioid and Alcohol) • Cognitive Disorders

Efficacy of oral naltrexone with buprenorphine for transitioning from buprenorphine to XR-NTX: A hybrid residential-outpatient randomized control trial (CPDD 2018) - No abstract available.

Clinical • Biosimilar

Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended-Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens. (PubMed, Am J Addict) - "Low ascending doses of oral NTX did not increase induction rates onto XR-NTX compared with placebo. 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)."

Clinical • Journal

Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone (clinicaltrials.gov) - P=N/A; N=6; Recruiting; Sponsor: The Cleveland Clinic; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Oct 2019 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date

Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. (PubMed, J Subst Abuse Treat) - "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."

Clinical • Journal

Transition From Buprenorphine Maintenance to Extended-Release Naltrexone: Hybrid ResidentialOutpatient Randomized Controlled Trial (APA 2019) - "...Methods This Phase 3, hybrid outpatient-residential study (N=101) evaluated the efficacy and safety of oral naltrexone (NTX) used in conjunction with BUP and a standing regimen of ancillary medications to help adults with OUD transition from BUP maintenance to XR-NTX. Participants maintained on daily BUP for at least 3 months (receiving at most 8mg for at least the previous 30 days) and seeking antagonist treatment were stabilized on BUP (at most 4mg) and randomized (1:1) to 7 residential days of low, ascending doses of oral NTX (NTX/BUP) or placeboNTX (PBO-N/BUP) in addition to a 3-day decreasing BUP taper, ancillary medications (clonidine, clonazepam, and trazodone), and daily psychoeducational counseling...The overall high rate of successful induction supports the use of a brief BUP taper in combination with standing ancillary medications as a welltolerated approach for patients seeking to transition from BUP to XR-NTX. Study was funded by Alkermes"

Clinical