Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
2 other identifiers
interventional
570
1 country
8
Brief Summary
CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery. The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid). The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2014
Typical duration for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
January 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2017
CompletedResults Posted
Study results publicly available
January 19, 2018
CompletedAugust 13, 2020
July 1, 2020
3 years
December 30, 2013
November 24, 2017
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to Relapse (Intent to Treat Population)
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Weeks 3-24
Time to Relapse (Per Protocol Population)
Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Weeks 3-24
Secondary Outcomes (56)
Number Successfully Inducted Onto Assigned Study Medication
Weeks 0-24
Adverse Events Related to Study Medications
Weeks 0-36
Opioid Abstinence Over Time While on Study Medication (Subjective)
Weeks 0-24
Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
Week 0
Cigarette Smoking, W0, 10 or Less
Week 0
- +51 more secondary outcomes
Study Arms (2)
Extended-Release Naltrexone
ACTIVE COMPARATORExtended-Release Naltrexone (Vivitrol)
Buprenorphine-Naloxone
ACTIVE COMPARATORBuprenorphine-Naloxone (Suboxone)
Interventions
Extended-Release Naltrexone (Vivitrol®)
Buprenorphine-Naloxone (Suboxone®)
Eligibility Criteria
You may qualify if:
- Male or female
- years of age and older
- Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)
- Have used opioids other than as specifically prescribed within thirty days prior to consent
- Seeking treatment for opioid dependence and willing to accept "agonist-based" or "antagonist-based" therapy
- In good-enough general health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX
- Able to provide written informed consent
- Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
- If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study
You may not qualify if:
- Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study. Examples include:
- Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
- Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
- Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)
- LFTs (ALT, AST) greater than 5 times upper limit of normal
- Suicidal or homicidal ideation that requires immediate attention
- Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent
- Maintenance on methadone at doses of 30mg or greater at the time of signing consent
- Presence of pain of sufficient severity as to require ongoing pain management with opioids
- Pending legal action or other reasons that might prevent an individual from completing the study
- If female, currently pregnant or breastfeeding, or planning on conception
- Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI\>40, excess fat tissue over the buttocks, emaciation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute on Drug Abuse (NIDA)collaborator
- The Emmes Company, LLCcollaborator
Study Sites (8)
Tarzana Treatment Centers
Tarzana, California, 91356, United States
Gateway Community Services, Inc.
Jacksonville, Florida, 32201, United States
Avery Road Treatment Center
Rockville, Maryland, 20853, United States
Stanley Street Treatment and Resources
Fall River, Massachusetts, 02720, United States
Turquoise Lodge Hospital
Albuquerque, New Mexico, 87108, United States
Bellevue Hospital Center
New York, New York, 10016, United States
Maryhaven
Columbus, Ohio, 43207, United States
Evergreen Treatment Services
Seattle, Washington, 98134, United States
Related Publications (13)
Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
PMID: 40342086DERIVEDBrandt L, Odom GJ, Hu MC, Castro C, Balise RR; CTN-0094 Team. Empirically contrasting urine drug screening-based opioid use disorder treatment outcome definitions. Addiction. 2024 Jul;119(7):1289-1300. doi: 10.1111/add.16494. Epub 2024 Apr 14.
PMID: 38616571DERIVEDFoot C, Korthuis PT, Tsui JI, Luo SX, Chan B, Cook RR. Associations between stimulant use and return to illicit opioid use following initiation onto medication for opioid use disorder. Addiction. 2024 Jan;119(1):149-157. doi: 10.1111/add.16334. Epub 2023 Sep 15.
PMID: 37712113DERIVEDNielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
PMID: 36063082DERIVEDTsui JI, Campbell ANC, Pavlicova M, Choo TH, Lee JD, Cook RR, Shulman M, Nunes EV, Rotrosen J. Methamphetamine/amphetamine use over time among persons with opioid use disorders treated with buprenorphine/naloxone versus extended-release naltrexone. Drug Alcohol Depend. 2022 Jul 1;236:109469. doi: 10.1016/j.drugalcdep.2022.109469. Epub 2022 Apr 21.
PMID: 35605529DERIVEDJelovac A, McLoughlin DM. Twelve-Month Outcomes for Remitters Following Electroconvulsive Therapy for Depression. J Clin Psychiatry. 2022 Apr 18;83(3):21lr14371. doi: 10.4088/JCP.21lr14371. No abstract available.
PMID: 35452195DERIVEDNa PJ, Scodes J, Fishman M, Rotrosen J, Nunes EV. Co-occurring Depression and Suicidal Ideation in Opioid Use Disorder: Prevalence and Response During Treatment With Buprenorphine-Naloxone and Injection Naltrexone. J Clin Psychiatry. 2022 Apr 18;83(3):21m14140. doi: 10.4088/JCP.21m14140.
PMID: 35452194DERIVEDRudolph KE, Shulman M, Fishman M, Diaz I, Rotrosen J, Nunes EV. Association between dynamic dose increases of buprenorphine for treatment of opioid use disorder and risk of relapse. Addiction. 2022 Mar;117(3):637-645. doi: 10.1111/add.15654. Epub 2021 Oct 1.
PMID: 34338389DERIVEDNunes EV Jr, Scodes JM, Pavlicova M, Lee JD, Novo P, Campbell ANC, Rotrosen J. Sublingual Buprenorphine-Naloxone Compared With Injection Naltrexone for Opioid Use Disorder: Potential Utility of Patient Characteristics in Guiding Choice of Treatment. Am J Psychiatry. 2021 Jul;178(7):660-671. doi: 10.1176/appi.ajp.2020.20060816. Epub 2021 Jun 25.
PMID: 34170188DERIVEDFishman M, Wenzel K, Scodes J, Pavlicova M, Campbell ANC, Rotrosen J, Nunes E. Examination of Correlates of OUD Outcomes in Young Adults: Secondary Analysis From the XBOT Trial. Am J Addict. 2021 Sep;30(5):433-444. doi: 10.1111/ajad.13176. Epub 2021 Jun 1.
PMID: 34075644DERIVEDShulman M, Choo TH, Scodes J, Pavlicova M, Wai J, Haenlein P, Tofighi B, Campbell ANC, Lee JD, Rotrosen J, Nunes EV. Association between methadone or buprenorphine use during medically supervised opioid withdrawal and extended-release injectable naltrexone induction failure. J Subst Abuse Treat. 2021 May;124:108292. doi: 10.1016/j.jsat.2021.108292. Epub 2021 Jan 16.
PMID: 33771287DERIVEDLee JD, Nunes EV Jr, Novo P, Bachrach K, Bailey GL, Bhatt S, Farkas S, Fishman M, Gauthier P, Hodgkins CC, King J, Lindblad R, Liu D, Matthews AG, May J, Peavy KM, Ross S, Salazar D, Schkolnik P, Shmueli-Blumberg D, Stablein D, Subramaniam G, Rotrosen J. Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018 Jan 27;391(10118):309-318. doi: 10.1016/S0140-6736(17)32812-X. Epub 2017 Nov 14.
PMID: 29150198DERIVEDLee JD, 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. NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale. Contemp Clin Trials. 2016 Sep;50:253-64. doi: 10.1016/j.cct.2016.08.004. Epub 2016 Aug 10.
PMID: 27521809DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Rotrosen
- Organization
- NYU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
John Rotrosen, MD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2013
First Posted
January 10, 2014
Study Start
January 29, 2014
Primary Completion
January 25, 2017
Study Completion
January 31, 2017
Last Updated
August 13, 2020
Results First Posted
January 19, 2018
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
Data from this study will be available to researchers on the website, http://datashare.nida.nih.gov/ after the study is complete and the data analyzed. This website will not include information that can identify individual study participants.