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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA013035 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended-Release Naltrexone | Active Comparator | Extended-Release Naltrexone (Vivitrol) |
|
| Buprenorphine-Naloxone | Active Comparator | Buprenorphine-Naloxone (Suboxone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended-Release Naltrexone | Drug | Extended-Release Naltrexone (Vivitrol®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 0-24 |
| Adverse Events Related to Study Medications |
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Inclusion Criteria
Exclusion Criteria
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
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)
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| Name | Affiliation | Role |
|---|---|---|
| John Rotrosen, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tarzana Treatment Centers | Tarzana | California | 91356 | United States | ||
| Gateway Community Services, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40643356 | Derived | 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. | |
| 40342086 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Extended-Release Naltrexone | Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®) |
| FG001 | Buprenorphine-Naloxone | Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adults with DSM-5 OUD with non prescribed opioid use in the past 30 days.
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended-Release Naltrexone | Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®) |
| BG001 | Buprenorphine-Naloxone | Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention to treat. | Posted | Median | 95% Confidence Interval | weeks | Weeks 3-24 |
|
Weeks 0-36
Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended-Release Naltrexone | Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Rotrosen | NYU School of Medicine | 646-754-4763 | john.rotrosen@nyumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2015 | Oct 30, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2017 | Nov 1, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Buprenorphine-Naloxone | Drug | Buprenorphine-Naloxone (Suboxone®) |
|
|
Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.
| 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. | 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 | Week 0 |
| Cigarette Smoking, W0, 10 or Less | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less. | Week 0 |
| Opioid Craving Over Time W0 | Opioid craving over time via VAS at week 0 | 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. | 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. | 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. | 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. | 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. | Weeks 0-24 |
| Cigarette Smoking, W0 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals none | Week 0 |
| Cigarette Smoking, W0 11-20 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20. | Week 0 |
| Cigarette Smoking, W0 21-30 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30 | Week 0 |
| Cigarette Smoking, W0 31 or More | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more | Week 0 |
| Cigarette Smoking, W24 0 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals none | Week 24 |
| Cigarette Smoking | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less. | Week 24 |
| Cigarette Smoking, W24 11-20 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20. | Week 24 |
| Cigarette Smoking, W24 21-30 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30 | Week 24 |
| Cigarette Smoking, W24 31 or More | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 24 |
| Alcohol Use Over Time, Drinks Per Day | Alcohol use over time, drinks per day | Week 24 |
| Other Drug Use Over Time, Cannabis, W0 | Other drug use over time measuring cannabis at week 0 | week 0 |
| Other Drug Use Over Time, Cannabis, W24 | Other drug use over time measuring cannabis at week 24 | week 24 |
| Other Drug Use Over Time, Cocaine, W0 | Other drug use over time measuring cocaine at week 0 | week 0 |
| Other Drug Use Over Time, Cocaine, W24 | Other drug use over time measuring cocaine at week 0 | week 24 |
| Other Drug Use Over Time, Stimulant, W0 | Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0 | week 0 |
| Other Drug Use Over Time, Stimulant, W24 | Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24 | week 24 |
| 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 |
| 38616571 | Derived | Brandt 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. |
| 37712113 | Derived | Foot 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. |
| 36063082 | Derived | Nielsen 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. |
| 35605529 | Derived | Tsui 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. |
| 35452195 | Derived | Jelovac 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. |
| 35452194 | Derived | Na 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. |
| 34338389 | Derived | Rudolph 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. |
| 34170188 | Derived | Nunes 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. |
| 34075644 | Derived | Fishman 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. |
| 33771287 | Derived | Shulman 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. |
| 29150198 | Derived | Lee 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. |
| 27521809 | Derived | Lee 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Randomization status | Count of Participants | Participants |
|
Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®) |
| OG001 | Buprenorphine-Naloxone | Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®) |
|
|
| Primary | 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. | Per protocol population (those successfully inducted onto medication) | Posted | Median | 95% Confidence Interval | weeks | Weeks 3-24 |
|
|
|
| Secondary | 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. | Intent to treat | Posted | Number | participants | Weeks 0-24 |
|
|
|
| Secondary | 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. | These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication. | Posted | Number | events | Weeks 0-36 |
|
|
|
| Secondary | 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. | per protocol | Posted | Median | Inter-Quartile Range | days | Weeks 0-24 |
|
|
|
| Secondary | Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 | Alcohol use over time, drinks per day, past 30 days, at week 0 | Posted | Mean | Standard Deviation | drinks per day | Week 0 |
|
|
|
| Secondary | Cigarette Smoking, W0, 10 or Less | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less. | Posted | Count of Participants | Participants | Week 0 |
|
|
|
| Secondary | Opioid Craving Over Time W0 | Opioid craving over time via VAS at week 0 | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 0 |
|
|
|
| Secondary | 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. | Per protocol | Posted | Median | Inter-Quartile Range | Weeks | Weeks 0-24 |
|
|
|
| Secondary | Cigarette Smoking, W0 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals none | Posted | Count of Participants | Participants | Week 0 |
|
|
|
| Secondary | Cigarette Smoking, W0 11-20 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20. | Posted | Count of Participants | Participants | Week 0 |
|
|
|
| Secondary | Cigarette Smoking, W0 21-30 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30 | Posted | Count of Participants | Participants | Week 0 |
|
|
|
| Secondary | Cigarette Smoking, W0 31 or More | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more | Posted | Count of Participants | Participants | Week 0 |
|
|
|
| Secondary | Cigarette Smoking, W24 0 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals none | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Cigarette Smoking | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Cigarette Smoking, W24 11-20 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Cigarette Smoking, W24 21-30 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30 | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Cigarette Smoking, W24 31 or More | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 0 |
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Alcohol Use Over Time, Drinks Per Day | Alcohol use over time, drinks per day | Posted | Mean | Standard Deviation | drinks per day | Week 24 |
|
|
|
| Secondary | Other Drug Use Over Time, Cannabis, W0 | Other drug use over time measuring cannabis at week 0 | Posted | Count of Participants | Participants | week 0 |
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|
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| Secondary | Other Drug Use Over Time, Cannabis, W24 | Other drug use over time measuring cannabis at week 24 | Posted | Count of Participants | Participants | week 24 |
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| Secondary | Other Drug Use Over Time, Cocaine, W0 | Other drug use over time measuring cocaine at week 0 | Posted | Count of Participants | Participants | week 0 |
|
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| Secondary | Other Drug Use Over Time, Cocaine, W24 | Other drug use over time measuring cocaine at week 0 | Posted | Count of Participants | Participants | week 24 |
|
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| Secondary | Other Drug Use Over Time, Stimulant, W0 | Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0 | Posted | Count of Participants | Participants | week 0 |
|
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| Secondary | Other Drug Use Over Time, Stimulant, W24 | Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24 | Posted | Count of Participants | Participants | week 24 |
|
|
|
| 3 |
| 283 |
| 41 |
| 283 |
| 118 |
| 283 |
| EG001 | Buprenorphine-Naloxone | Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®) | 4 | 287 | 31 | 287 | 135 | 287 |
| Infections and infestations | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Psychiatric | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Injury poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| General Disorders and Administration Site Conditions | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Metabolism and nutrition | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Hepatbiliary disorders | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Immune system disorders | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Social circumstances | Social circumstances | MedDRA (19.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Product issues | Product Issues | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |