Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)”
Abstract Opioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2021-03-01
|
| Series: | Addiction Science & Clinical Practice |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13722-021-00223-z |
| _version_ | 1818848060447391744 |
|---|---|
| author | Matisyahu Shulman Roger Weiss John Rotrosen Patricia Novo Elizabeth Costello Edward V. Nunes |
| author_facet | Matisyahu Shulman Roger Weiss John Rotrosen Patricia Novo Elizabeth Costello Edward V. Nunes |
| author_sort | Matisyahu Shulman |
| collection | DOAJ |
| description | Abstract Opioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study “Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy” (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials. |
| first_indexed | 2024-12-19T06:11:20Z |
| format | Article |
| id | doaj.art-3d71d775cbb0421ca897d5ff79e9d22c |
| institution | Directory Open Access Journal |
| issn | 1940-0640 |
| language | English |
| last_indexed | 2024-12-19T06:11:20Z |
| publishDate | 2021-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Addiction Science & Clinical Practice |
| spelling | doaj.art-3d71d775cbb0421ca897d5ff79e9d22c2022-12-21T20:32:59ZengBMCAddiction Science & Clinical Practice1940-06402021-03-0116111010.1186/s13722-021-00223-zPrior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)”Matisyahu Shulman0Roger Weiss1John Rotrosen2Patricia Novo3Elizabeth Costello4Edward V. Nunes5New York State Psychiatric Institute and Columbia University Irving Medical CenterMcLean Hospital and Harvard Medical SchoolNew York University Grossman School of MedicineNew York University Grossman School of MedicineNew York State Psychiatric Institute and Columbia University Irving Medical CenterNew York State Psychiatric Institute and Columbia University Irving Medical CenterAbstract Opioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study “Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy” (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials.https://doi.org/10.1186/s13722-021-00223-zOpioid use disorderBuprenorphineNaltrexoneClinical trials |
| spellingShingle | Matisyahu Shulman Roger Weiss John Rotrosen Patricia Novo Elizabeth Costello Edward V. Nunes Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)” Addiction Science & Clinical Practice Opioid use disorder Buprenorphine Naltrexone Clinical trials |
| title | Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)” |
| title_full | Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)” |
| title_fullStr | Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)” |
| title_full_unstemmed | Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)” |
| title_short | Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)” |
| title_sort | prior national drug abuse treatment clinical trials network ctn opioid use disorder trials as background and rationale for nida ctn 0100 optimizing retention duration and discontinuation strategies for opioid use disorder pharmacotherapy rdd |
| topic | Opioid use disorder Buprenorphine Naltrexone Clinical trials |
| url | https://doi.org/10.1186/s13722-021-00223-z |
| work_keys_str_mv | AT matisyahushulman priornationaldrugabusetreatmentclinicaltrialsnetworkctnopioidusedisordertrialsasbackgroundandrationalefornidactn0100optimizingretentiondurationanddiscontinuationstrategiesforopioidusedisorderpharmacotherapyrdd AT rogerweiss priornationaldrugabusetreatmentclinicaltrialsnetworkctnopioidusedisordertrialsasbackgroundandrationalefornidactn0100optimizingretentiondurationanddiscontinuationstrategiesforopioidusedisorderpharmacotherapyrdd AT johnrotrosen priornationaldrugabusetreatmentclinicaltrialsnetworkctnopioidusedisordertrialsasbackgroundandrationalefornidactn0100optimizingretentiondurationanddiscontinuationstrategiesforopioidusedisorderpharmacotherapyrdd AT patricianovo priornationaldrugabusetreatmentclinicaltrialsnetworkctnopioidusedisordertrialsasbackgroundandrationalefornidactn0100optimizingretentiondurationanddiscontinuationstrategiesforopioidusedisorderpharmacotherapyrdd AT elizabethcostello priornationaldrugabusetreatmentclinicaltrialsnetworkctnopioidusedisordertrialsasbackgroundandrationalefornidactn0100optimizingretentiondurationanddiscontinuationstrategiesforopioidusedisorderpharmacotherapyrdd AT edwardvnunes priornationaldrugabusetreatmentclinicaltrialsnetworkctnopioidusedisordertrialsasbackgroundandrationalefornidactn0100optimizingretentiondurationanddiscontinuationstrategiesforopioidusedisorderpharmacotherapyrdd |