Opioid Use DisorderPhase 4NCT02032433
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
A Phase 4 study testing Extended-Release Naltrexone and Buprenorphine-Naloxone in people with Opioid Use Disorder, run by NYU Langone Health at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Extended-Release Naltrexone and Buprenorphine-Naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Jan 2014to 31 Jan 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Turquoise Lodge Hospital
Albuquerque, New Mexico, 87108
Maryhaven
Columbus, Ohio, 43207
Stanley Street Treatment and Resources
Fall River, Massachusetts, 02720
Gateway Community Services, Inc.
Jacksonville, Florida, 32201
Bellevue Hospital Center
New York, New York, 10016
Avery Road Treatment Center
Rockville, Maryland, 20853
Evergreen Treatment Services
Seattle, Washington, 98134
Tarzana Treatment Centers
Tarzana, California, 91356
About this study
Official title: CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
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.
Read the detailed description
For opioid-dependent patients in the U.S. and most of the rest of the world, detoxification or detoxification followed by short term residential treatment, with the goal of achieving long-term abstinence from opioid misuse is a mainstay of treatment. Nonetheless, the majority of patients treated in this way will relapse to opioid misuse, leading to a costly and ineffectual cycle of readmission for repeated detoxifications.
The overarching goal of CTN-0051 is to foster adoption of new relapse-prevention pharmacotherapies in community-based treatment programs (CTPs) where these could have a substantial public health impact. To this end 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 CTN-affiliated CTPs that provide or partner with detoxification services (inpatient/residential) which have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide medication-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period. 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). To maximize generalizability, the point of randomization is flexible, from shortly after program admission until just prior to program discharge. A data analysis modification (assessment of whether the early vs. late randomizers have a differential treatment effect and if so, time to relapse will be estimated for early and late randomizers separately) will occur if differential treatment initiation is a problem for cases randomized prior to completing detoxification (i.e., significantly fewer early randomizers are able to complete detoxification and XR-NTX induction).
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. The primary outcome measure will be the time to the event, with the event called relapse. 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.
Toward the end of the 24-week treatment period, participants are referred for follow-up care in the community (which could include pharmacotherapy if desired and available), and follow-up outcomes are assessed at week 28 and week 36 after randomization. For participants receiving BUP-NX, who do not wish to continue, or for whom community resources are not available, the study provides a two-week BUP-NX taper.
In an ancillary genetics study we plan to study functional variants in three genes (OPRM1, OPRK1 and PDYN), known to affect the dynamic response to opioid receptor ligands. These variants will be evaluated in CTN-0051 for their contribution to treatment retention, abstinence, and depression. Blood collection for DNA extraction will occur at the same time that blood is collected for medical safety and liver function evaluation, precluding the need for an additional needle-stick. Coded blood samples for the genetics studies will be sent to the NIDA Center for Genetics Repository.
- Conditions
- Opioid Use Disorder
- Being tested
- Extended-Release Naltrexone, Buprenorphine-Naloxone
- Keywords
- extended-release naltrexone (Vivitrol), buprenorphine-naloxone (Suboxone), comparative effective, relapse prevention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release NaltrexoneDrug
Also called Vivitrol®
Extended-Release Naltrexone (Vivitrol®)
Buprenorphine-NaloxoneDrug
Also called Suboxone®
Buprenorphine-Naloxone (Suboxone®)
| Study group | Role | What they receive |
|---|---|---|
| Extended-Release Naltrexone | Active comparator | Extended-Release Naltrexone (Vivitrol) Receives: Drug: Extended-Release Naltrexone |
| Buprenorphine-Naloxone | Active comparator | Buprenorphine-Naloxone (Suboxone) Receives: Drug: Buprenorphine-Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weeks 3-24
Secondary outcomes (56)
Number Successfully Inducted Onto Assigned Study Medication
Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.
Measured: Weeks 0-24
Adverse Events Related to Study Medications
Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.
Measured: Weeks 0-36
Opioid Abstinence Over Time While on Study Medication (Subjective)
Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.
Measured: Weeks 0-24
Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
Alcohol use over time, drinks per day, past 30 days, at week 0
Measured: Week 0
Cigarette Smoking, W0, 10 or Less
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.
Measured: Week 0
Opioid Craving Over Time W0
Opioid craving over time via VAS at week 0
Measured: Week 0
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Measured: Week 0
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 0
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Measured: Week 0
Score on Trail Making Test Part A
Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Measured: Week 0
Opioid Abstinence Over Time While on Study Medication (Objective)
A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.
Measured: Weeks 0-24
Cigarette Smoking, W0 0
Participants average cigarettes/day, in past 4 weeks, at week 0, equals none
Measured: Week 0
Cigarette Smoking, W0 11-20
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.
Measured: Week 0
Cigarette Smoking, W0 21-30
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30
Measured: Week 0
Cigarette Smoking, W0 31 or More
Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more
Measured: Week 0
Cigarette Smoking, W24 0
Participants average cigarettes/day, in past 4 weeks, at week 24, equals none
Measured: Week 24
Cigarette Smoking
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.
Measured: Week 24
Cigarette Smoking, W24 11-20
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.
Measured: Week 24
Cigarette Smoking, W24 21-30
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30
Measured: Week 24
Cigarette Smoking, W24 31 or More
Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more
Measured: Week 24
Score on Opioid Craving Scale (OCS)
OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.
Measured: Week 24
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Measured: Week 24
Score on Subjective Opiate Withdrawal Scale (SOWS)
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Measured: Week 0
Score on Subjective Opiate Withdrawal Scale (SOWS)
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Measured: Week 24
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Measured: Week 24
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Measured: Week 0
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Measured: Week 24
Score on Trail Making Test Part A
Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Measured: Week 24
Score on Trail Making Test Part B
Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Measured: Week 0
Score on Trail Making Test Part B
Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Measured: Week 24
Score on Word Card of Stoop Test
The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Measured: Week 0
Score on Word Card of Stoop Test
The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Measured: Week 24
Score on Color Card of Stoop Test
The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Measured: Week 0
Score on Color Card of Stoop Test
The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Measured: Week 24
Score on Color Word Card of Stoop Test
The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Measured: Week 0
Score on Color Word Card of Stoop Test
The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Measured: Week 24
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 24
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 0
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 24
Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Measured: Week 0
Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Measured: Week 24
Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 0
Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 24
Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 0
Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 24
Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 0
Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Measured: Week 24
Score on EuroQOL EQ-5D Questionnaire
Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Measured: Week 0
Score on EuroQOL EQ-5D Questionnaire
Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Measured: Week 24
Alcohol Use Over Time, Drinks Per Day
Alcohol use over time, drinks per day
Measured: Week 24
Other Drug Use Over Time, Cannabis, W0
Other drug use over time measuring cannabis at week 0
Measured: week 0
Other Drug Use Over Time, Cannabis, W24
Other drug use over time measuring cannabis at week 24
Measured: week 24
Other Drug Use Over Time, Cocaine, W0
Other drug use over time measuring cocaine at week 0
Measured: week 0
Other Drug Use Over Time, Cocaine, W24
Other drug use over time measuring cocaine at week 0
Measured: week 24
Other Drug Use Over Time, Stimulant, W0
Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0
Measured: week 0
Other Drug Use Over Time, Stimulant, W24
Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study start29 Jan 2014
- Primary completion25 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- John Rotrosen, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032433
- Sponsor's protocol ID
- 12-03133
- Other IDs
- UG1DA013035
- Status last verified
- Jul 2020
- First submitted
- 30 Dec 2013
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Rizk MM, Stanley B, Choo TH, Pavlicova M, Scodes JM, Rotrosen J, Nunes EV. Suicidal ideation in adults with opioid use disorder treated with buprenorphine-naloxone versus extended-release naltrexone. Am J Drug Alcohol Abuse. 2025;51(5):658-666. doi: 10.1080/00952990.2025.2524110. Epub 2025 Jul 11.
PubMed 40643356Kornor 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.
PubMed 40342086Brandt 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.
PubMed 38616571Foot 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.
PubMed 37712113Nielsen 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.
PubMed 36063082Tsui 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.
PubMed 35605529Jelovac 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.
PubMed 35452195Na 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.
PubMed 35452194Rudolph 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.
PubMed 34338389Nunes 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.
PubMed 34170188Fishman 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.
PubMed 34075644Shulman 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.
PubMed 33771287Lee 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.
PubMed 29150198Lee 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.
PubMed 27521809
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
- ClinicalTrials.gov ID
- NCT02032433
- Acronym / sponsor ID
- 12-03133
- Conditions
- Opioid Use Disorder
- Keywords
- extended-release naltrexone (Vivitrol), buprenorphine-naloxone (Suboxone), comparative effective, relapse prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 19 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For opioid-dependent patients in the U.S. and most of the rest of the world, detoxification or detoxification followed by short term residential treatment, with the goal of achieving long-term abstinence from opioid misuse is a mainstay of treatment. Nonetheless, the majority of patients treated in this way will relapse to opioid misuse, leading to a costly and ineffectual cycle of readmission for repeated detoxifications.
The overarching goal of CTN-0051 is to foster adoption of new relapse-prevention pharmacotherapies in community-based treatment programs (CTPs) where these could have a substantial public health impact. To this end 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 CTN-affiliated CTPs that provide or partner with detoxification services (inpatient/residential) which have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide medication-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period. 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). To maximize generalizability, the point of randomization is flexible, from shortly after program admission until just prior to program discharge. A data analysis modification (assessment of whether the early vs. late randomizers have a differential treatment effect and if so, time to relapse will be estimated for early and late randomizers separately) will occur if differential treatment initiation is a problem for cases randomized prior to completing detoxification (i.e., significantly fewer early randomizers are able to complete detoxification and XR-NTX induction).
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. The primary outcome measure will be the time to the event, with the event called relapse. 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.
Toward the end of the 24-week treatment period, participants are referred for follow-up care in the community (which could include pharmacotherapy if desired and available), and follow-up outcomes are assessed at week 28 and week 36 after randomization. For participants receiving BUP-NX, who do not wish to continue, or for whom community resources are not available, the study provides a two-week BUP-NX taper.
In an ancillary genetics study we plan to study functional variants in three genes (OPRM1, OPRK1 and PDYN), known to affect the dynamic response to opioid receptor ligands. These variants will be evaluated in CTN-0051 for their contribution to treatment retention, abstinence, and depression. Blood collection for DNA extraction will occur at the same time that blood is collected for medical safety and liver function evaluation, precluding the need for an additional needle-stick. Coded blood samples for the genetics studies will be sent to the NIDA Center for Genetics Repository.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-Release Naltrexone | Active comparator | Drug: Extended-Release NaltrexoneExtended-Release Naltrexone (Vivitrol) |
| Buprenorphine-Naloxone | Active comparator | Drug: Buprenorphine-NaloxoneBuprenorphine-Naloxone (Suboxone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- 18 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
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-Release NaltrexoneAlso: Vivitrol®Extended-Release Naltrexone (Vivitrol®) | Drug | Extended-Release Naltrexone |
| Buprenorphine-NaloxoneAlso: Suboxone®Buprenorphine-Naloxone (Suboxone®) | Drug | Buprenorphine-Naloxone |
Primary outcome
Time to Relapse (Intent to Treat Population)
Time frame: Weeks 3-24
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.
Time to Relapse (Per Protocol Population)
Time frame: Weeks 3-24
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.
56 secondary outcomes
Number Successfully Inducted Onto Assigned Study Medication
Time frame: Weeks 0-24
Adverse Events Related to Study Medications
Time frame: Weeks 0-36
Opioid Abstinence Over Time While on Study Medication (Subjective)
Time frame: Weeks 0-24
Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
Time frame: Week 0
Cigarette Smoking, W0, 10 or Less
Time frame: Week 0
Opioid Craving Over Time W0
Time frame: Week 0
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
Time frame: Week 0
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
Time frame: Week 0
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Time frame: Week 0
Score on Trail Making Test Part A
Time frame: Week 0
Opioid Abstinence Over Time While on Study Medication (Objective)
Time frame: Weeks 0-24
Cigarette Smoking, W0 0
Time frame: Week 0
Cigarette Smoking, W0 11-20
Time frame: Week 0
Cigarette Smoking, W0 21-30
Time frame: Week 0
Cigarette Smoking, W0 31 or More
Time frame: Week 0
Cigarette Smoking, W24 0
Time frame: Week 24
Cigarette Smoking
Time frame: Week 24
Cigarette Smoking, W24 11-20
Time frame: Week 24
Cigarette Smoking, W24 21-30
Time frame: Week 24
Cigarette Smoking, W24 31 or More
Time frame: Week 24
Score on Opioid Craving Scale (OCS)
Time frame: Week 24
Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
Time frame: Week 24
Score on Subjective Opiate Withdrawal Scale (SOWS)
Time frame: Week 0
Score on Subjective Opiate Withdrawal Scale (SOWS)
Time frame: Week 24
Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Time frame: Week 24
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Time frame: Week 0
Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Time frame: Week 24
Score on Trail Making Test Part A
Time frame: Week 24
Score on Trail Making Test Part B
Time frame: Week 0
Score on Trail Making Test Part B
Time frame: Week 24
Score on Word Card of Stoop Test
Time frame: Week 0
Score on Word Card of Stoop Test
Time frame: Week 24
Score on Color Card of Stoop Test
Time frame: Week 0
Score on Color Card of Stoop Test
Time frame: Week 24
Score on Color Word Card of Stoop Test
Time frame: Week 0
Score on Color Word Card of Stoop Test
Time frame: Week 24
Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
Time frame: Week 24
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
Time frame: Week 0
Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
Time frame: Week 24
Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
Time frame: Week 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40643356Rizk MM, Stanley B, Choo TH, Pavlicova M, Scodes JM, Rotrosen J, Nunes EV. Suicidal ideation in adults with opioid use disorder treated with buprenorphine-naloxone versus extended-release naltrexone. Am J Drug Alcohol Abuse. 2025;51(5):658-666. doi: 10.1080/00952990.2025.2524110. Epub 2025 Jul 11.
- Derived from this study: PubMed 40342086Kornor 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.
- Derived from this study: PubMed 38616571Brandt 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.
- Derived from this study: PubMed 37712113Foot 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.
- Derived from this study: PubMed 36063082Nielsen 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.
- Derived from this study: PubMed 35605529Tsui 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.
- Derived from this study: PubMed 35452195Jelovac 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.
- Derived from this study: PubMed 35452194Na 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.
- Derived from this study: PubMed 34338389Rudolph 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.
- Derived from this study: PubMed 34170188Nunes 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.
- Derived from this study: PubMed 34075644Fishman 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.
- Derived from this study: PubMed 33771287Shulman 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Rotrosen, MD principal investigator
NYU Langone Health
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extended-Release Naltrexone and Buprenorphine-Naloxone in people with Opioid Use Disorder, run by NYU Langone Health at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Relapse (Intent to Treat Population) (time frame: Weeks 3-24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02032433, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.