TY - JOUR
T1 - NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT)
T2 - Study design and rationale
AU - Lee, Joshua D.
AU - Nunes, Edward V.
AU - MPA, Patricia Novo
AU - Bailey, Genie L.
AU - Brigham, Gregory S.
AU - Cohen, Allan J.
AU - Fishman, Marc
AU - Ling, Walter
AU - Lindblad, Robert
AU - Shmueli-Blumberg, Dikla
AU - Stablein, Don
AU - May, Jeanine
AU - Salazar, Dagmar
AU - Liu, David
AU - Rotrosen, John
N1 - Funding Information:
Dr. Lee has received investigator-initiated study funding and study drug in-kind from Alkermes for additional studies. Dr. Nunes received: study drug in-kind from Alkermes/Cephalon, Inc., Reckitt-Benckiser, and Duramed Pharmaceuticals for additional studies; web-based behavioral intervention for a research study from HealthSim, LLC; devices under investigation and reimbursement for travel for investigators' meeting from Brainsway. Dr. Nunes was paid an honorarium and received reimbursement for travel for attendance at a Lilly Advisory Board Meeting in January 2012 and received educational materials from Otsuka America Pharmaceutical, Inc. in 2013. He served on an Advisory Board for Alkermes. Dr. Rotrosen has been an investigator or co-investigator on studies for which Alkermes and Reckitt-Benckiser (Indivior) have provided medication and funding. He has no consulting or advisory board roles and has not received any fees, honoraria or other remuneration. Dr. Fishman has been a co-investigator on a study for which Alkermes have provided medication. He has served on an Advisory Board for US World Meds and been an investigator on studies for which they provided funding. Dr. Bailey's institution has received grant support from NIDA, Titan Pharmaceuticals, Inc., Alkermes, Inc., BioDelivery Sciences International, Inc., Orexo and Braeburn Pharmaceuticals. She has received study drug-in kind from Reckitt-Benckiser (Indivior). Dr. Bailey has received travel support from Titan Pharmaceuticals, Inc. and is on the advisory boards of Braeburn Pharmaceuticals, BioDelivery Sciences International, Inc. and Camurus AB. She is on the speakers bureau of Bio Delivery Sciences International, Inc.
Funding Information:
This work was supported by the National Institute on Drug Abuse Clinical Trials Network grants U10DA013046 (NYU, New York Node), U10DA013035 (RFMH, Greater New York Node), UG1DA013035 (NYU, Greater New York Node), U10DA013732 (OVN, Ohio Valley Node), and NIDA Contracts HHSN271201500065C (CCC, The Emmes Corp.) and HHSN271201200017C (DSC, The Emmes Corp.), K24 DA022412 (Dr. Nunes). Indivior (formerly, Reckitt Benckiser) provided Suboxone Film in-kind.
Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Introduction For opioid-dependent patients in the US and elsewhere, detoxification and counseling-only aftercare are treatment mainstays. Long-term abstinence is rarely achieved; many patients relapse and overdose after detoxification. Methadone, buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX) can prevent opioid relapse but are underutilized. This study is intended to develop an evidence-base to help patients and providers make informed choices and to foster wider adoption of relapse-prevention pharmacotherapies. Methods The National Institute on Drug Abuse's Clinical Trials Network (CTN) study CTN-0051, X:BOT, is a comparative effectiveness study of treatment for 24 weeks with XR-NTX, an opioid antagonist, versus BUP-NX, a high affinity partial opioid agonist, for opioid dependent patients initiating treatment at 8 short-term residential (detoxification) units and continuing care as outpatients. Up to 600 participants are randomized (1:1) to XR-NTX or BUP-NX. Results The primary outcome is time to opioid relapse (i.e., loss of persistent abstinence) across the 24-week treatment phase. Differences between arms in the distribution of time-to-relapse will be compared (construction of the asymptotic 95% CI for the hazard ratio of the difference between arms). Secondary outcomes include proportions retained in treatment, rates of opioid abstinence, adverse events, cigarette, alcohol, and other drug use, and HIV risk behaviors; opioid cravings, quality of life, cognitive function, genetic moderators, and cost effectiveness. Conclusions XR-NTX and BUP-NX differ considerably in their characteristics and clinical management; no studies to date have compared XR-NTX with buprenorphine maintenance. Study design choices and compromises inherent to a comparative effectiveness trial of distinct treatment regimens are reviewed. Clinical Trial Registration: NCT02032433.
AB - Introduction For opioid-dependent patients in the US and elsewhere, detoxification and counseling-only aftercare are treatment mainstays. Long-term abstinence is rarely achieved; many patients relapse and overdose after detoxification. Methadone, buprenorphine-naloxone (BUP-NX) and extended-release naltrexone (XR-NTX) can prevent opioid relapse but are underutilized. This study is intended to develop an evidence-base to help patients and providers make informed choices and to foster wider adoption of relapse-prevention pharmacotherapies. Methods The National Institute on Drug Abuse's Clinical Trials Network (CTN) study CTN-0051, X:BOT, is a comparative effectiveness study of treatment for 24 weeks with XR-NTX, an opioid antagonist, versus BUP-NX, a high affinity partial opioid agonist, for opioid dependent patients initiating treatment at 8 short-term residential (detoxification) units and continuing care as outpatients. Up to 600 participants are randomized (1:1) to XR-NTX or BUP-NX. Results The primary outcome is time to opioid relapse (i.e., loss of persistent abstinence) across the 24-week treatment phase. Differences between arms in the distribution of time-to-relapse will be compared (construction of the asymptotic 95% CI for the hazard ratio of the difference between arms). Secondary outcomes include proportions retained in treatment, rates of opioid abstinence, adverse events, cigarette, alcohol, and other drug use, and HIV risk behaviors; opioid cravings, quality of life, cognitive function, genetic moderators, and cost effectiveness. Conclusions XR-NTX and BUP-NX differ considerably in their characteristics and clinical management; no studies to date have compared XR-NTX with buprenorphine maintenance. Study design choices and compromises inherent to a comparative effectiveness trial of distinct treatment regimens are reviewed. Clinical Trial Registration: NCT02032433.
KW - Buprenorphine-naloxone
KW - Clinical trials network
KW - Extended-release naltrexone
KW - Medication assisted therapy
KW - Methods or experimental design
KW - Opioid dependence
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U2 - 10.1016/j.cct.2016.08.004
DO - 10.1016/j.cct.2016.08.004
M3 - Article
C2 - 27521809
AN - SCOPUS:84987639408
SN - 1551-7144
VL - 50
SP - 253
EP - 264
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -