NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X

BOT): Study design and rationale

Joshua Lee, Edward V. Nunes, Patricia Novo MPA, Genie L. Bailey, Gregory S. Brigham, Allan J. Cohen, Marc Fishman, Walter Ling, Robert Lindblad, Dikla Shmueli-Blumberg, Don Stablein, Jeanine May, Dagmar Salazar, David Liu, John Rotrosen

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)253-264
Number of pages12
JournalContemporary Clinical Trials
Volume50
DOIs
StatePublished - Sep 1 2016

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Buprenorphine
Naltrexone
Opioid Analgesics
Clinical Trials
Recurrence
Therapeutics
National Institute on Drug Abuse (U.S.)
Aftercare
Narcotic Antagonists
Methadone
Ambulatory Care
Risk-Taking
Secondary Prevention
N-nitrosoiminodiacetic acid
Tobacco Products
Cognition
Cost-Benefit Analysis
Counseling
Alcohols
Quality of Life

Keywords

  • Buprenorphine-naloxone
  • Clinical trials network
  • Extended-release naltrexone
  • Medication assisted therapy
  • Methods or experimental design
  • Opioid dependence

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X : BOT): Study design and rationale. / Lee, Joshua; Nunes, Edward V.; MPA, Patricia Novo; Bailey, Genie L.; Brigham, Gregory S.; Cohen, Allan J.; Fishman, Marc; Ling, Walter; Lindblad, Robert; Shmueli-Blumberg, Dikla; Stablein, Don; May, Jeanine; Salazar, Dagmar; Liu, David; Rotrosen, John.

In: Contemporary Clinical Trials, Vol. 50, 01.09.2016, p. 253-264.

Research output: Contribution to journalArticle

Lee, J, Nunes, EV, MPA, PN, Bailey, GL, Brigham, GS, Cohen, AJ, Fishman, M, Ling, W, Lindblad, R, Shmueli-Blumberg, D, Stablein, D, May, J, Salazar, D, Liu, D & Rotrosen, J 2016, 'NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X: BOT): Study design and rationale', Contemporary Clinical Trials, vol. 50, pp. 253-264. https://doi.org/10.1016/j.cct.2016.08.004
Lee, Joshua ; Nunes, Edward V. ; MPA, Patricia Novo ; Bailey, Genie L. ; Brigham, Gregory S. ; Cohen, Allan J. ; Fishman, Marc ; Ling, Walter ; Lindblad, Robert ; Shmueli-Blumberg, Dikla ; Stablein, Don ; May, Jeanine ; Salazar, Dagmar ; Liu, David ; Rotrosen, John. / NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X : BOT): Study design and rationale. In: Contemporary Clinical Trials. 2016 ; Vol. 50. pp. 253-264.
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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.",
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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

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AU - Stablein, Don

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AU - Salazar, Dagmar

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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.

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