title: NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale.
abstract: 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.
  
  
  
  The National Institute on Drug Abuse's Clinical Trials Network (CTN) study CTN-0051, X:BOT, is a comparative effectiveness study of treatment for 24weeks 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02032433.
authors: New York University School of Medicine, New York, NY, United States. Electronic address: joshua.lee@nyumc.org.
authors: Joshua D
authors: JD
authors: Lee
authors: New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, United States.
authors: Edward V
authors: EV
authors: Nunes
authors: New York University School of Medicine, New York, NY, United States.
authors: Patricia Novo
authors: PN
authors: Mpa
authors: Warren Alpert Medical School, Brown University, Providence, RI, United States; Stanley Street Treatment & Resources, Fall River, MA, United States.
authors: Genie L
authors: GL
authors: Bailey
authors: Adapt, Roseburg, OR, United States.
authors: Gregory S
authors: GS
authors: Brigham
authors: Bay Area Addiction Research & Treatment, San Francisco, CA, United States.
authors: Allan J
authors: AJ
authors: Cohen
authors: Mountain Manor Treatment Center, Baltimore, MD, United States.
authors: Marc
authors: M
authors: Fishman
authors: UCLA Integrated Substance Abuse Program, Los Angeles, CA, United States.
authors: Walter
authors: W
authors: Ling
authors: The Emmes Corporation, Rockville, MD, United States.
authors: Robert
authors: R
authors: Lindblad
authors: The Emmes Corporation, Rockville, MD, United States.
authors: Dikla
authors: D
authors: Shmueli-Blumberg
authors: The Emmes Corporation, Rockville, MD, United States.
authors: Don
authors: D
authors: Stablein
authors: The Emmes Corporation, Rockville, MD, United States.
authors: Jeanine
authors: J
authors: May
authors: The Emmes Corporation, Rockville, MD, United States.
authors: Dagmar
authors: D
authors: Salazar
authors: National Institute on Drug Abuse, Rockville, MD, United States.
authors: David
authors: D
authors: Liu
authors: New York University School of Medicine, New York, NY, United States.
authors: John
authors: J
authors: Rotrosen
mesh_terms: D000069479:Buprenorphine, Naloxone Drug Combination / Q000191:economics / Q000627:therapeutic use*; D057186:Comparative Effectiveness Research / Q000379:methods*; D003362:Cost-Benefit Analysis; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000191:economics / Q000627:therapeutic use*; D054577:National Institute on Drug Abuse (U.S.); D009293:Opioid-Related Disorders / Q000188:drug therapy*; D012959:Socioeconomic Factors; D014481:United States
chemical_list: D000069479:Buprenorphine, Naloxone Drug Combination; D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Buprenorphine-naloxone; Clinical trials network; Extended-release naltrexone; Medication assisted therapy; Methods or experimental design; Opioid dependence