NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale

• Published in: Contemporary clinical trials Vol. 50; pp. 253 - 264
• Main Authors: Lee, Joshua D., MD, MSc, Nunes, Edward V., MD, MPA, Patricia Novo, MPH, Bailey, Genie L., MD, Brigham, Gregory S., PhD, Cohen, Allan J., MA, MFT, Fishman, Marc, MD, Ling, Walter, MD, Lindblad, Robert, MD, Shmueli-Blumberg, Dikla, PhD, Stablein, Don, PhD, May, Jeanine, PhD, Salazar, Dagmar, MS, Liu, David, MD, Rotrosen, John, MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2016
• Subjects: Buprenorphine, Naloxone Drug Combination - economics; Buprenorphine, Naloxone Drug Combination - therapeutic use; Buprenorphine-naloxone; Cardiovascular; Clinical trials network; Comparative Effectiveness Research - methods; Cost-Benefit Analysis; Delayed-Action Preparations; Extended-release naltrexone; Female; Hematology, Oncology and Palliative Medicine; Humans; Injections, Intramuscular; Male; Medication assisted therapy; Methods or experimental design; Naltrexone - administration & dosage; Naltrexone - economics; Naltrexone - therapeutic use; Narcotic Antagonists - economics; Narcotic Antagonists - therapeutic use; National Institute on Drug Abuse (U.S.); Opioid dependence; Opioid-Related Disorders - drug therapy; Socioeconomic Factors; United States; E xtended-release naltrexone; M edication assisted therapy; O pioid dependence; M ethods or experimental design; B uprenorphine-naloxone; Clinical t rials n etwork; Buprenorphine-naloxone; Opioid dependence; Clinical trials network; Methods or experimental design; Extended-release naltrexone; Medication assisted therapy
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2016.08.004

Abstract 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.