Trial · NCT02510014

Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder

NCT02510014, Phase 3, Completed, Indivior Inc.; results first posted 2018-03-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder. Trials, record NCT02510014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02510014

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
NCT number: NCT02510014
Status: Completed
Phases: Phase 3
Enrollment: 775 participants, actual
Lead sponsor: Indivior Inc.
Conditions: Opioid Use Disorder, Opioid-related Disorders
Interventions: SUBOXONE sublingual film, RBP-6000
First posted: 2015-07-28
Last updated: 2018-03-29
Results first posted: 2018-03-29

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)	TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition.
Primary	Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs	Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	Vital signs include * systolic blood pressure (mmHg) * diastolic blood pressure (mmHg) * respiratory rate (breaths/minute) * weight (kg) * body mass index (kg/m\^2) * waist-to-hip ratio Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1.
Primary	Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period	Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. Only the most severe assessment is reported in this summary. Participants who experienced suicidal ideation and suicidal behavior are only summarized in the suicidal behavior since behavior is more severe than ideation. C-SSRS baseline version was completed during the screening visit. C-SSRS 'since-last-visit' version was completed weekly for the first month and at least every month until the end of the study. Shift table category titles are structured as: baseline category/treatment category. The category 'No Suicidal Ideation or Behaviour' has been abbreviated as 'No Suicidal I or B'.
Primary	Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)	De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141	Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain. The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection. Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented. De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309. Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141.
Secondary	Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)	Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values.
Secondary	Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)	Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values.
Secondary	Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)	Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values.
Secondary	Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49)	Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25	Participants' self-reported illicit opioid drug use from the timeline followback (TLFB) interview and results from the urine drug screens (UDS) for opioids were combined into a single endpoint. Opioids assessed included codeine, hydrocodone, hydromorphone, methadone, morphine, opiates, oxycodone, and oxymorphone (by UDS) and amphetamine/methadone, buprenorphine, methadone, and opioids in the TLFB. Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. All missing reports for opioids were considered nonnegative.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)	Safety analysis set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs	Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	Safety analysis set of participants with both a baseline and end of study reading	percentage change from baseline	MEAN
PRIMARY	Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period	Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	Safety population. Four de novo subjects and one roll-over subject are not reported because they used the C-SSRS baseline version throughout the study.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)	De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141	Safety analysis set	units on a scale	MEAN
SECONDARY	Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)	Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	Safety analysis set	units on a scale	MEAN
SECONDARY	Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)	Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	Safety analysis set	units on a scale	MEAN
SECONDARY	Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)	Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)	Safety analysis set	units on a scale	MEAN
SECONDARY	Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49)	Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25	Safety analysis set	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group101

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	De Novo Subjects	>=1 TEAE	302	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	Roll-over Subjects	>=1 TEAE	145	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	De Novo Subjects	>=1 TEAE related to study drug	172	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	Roll-over Subjects	>=1 TEAE related to study drug	61	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	De Novo Subjects	>=1 serious TEAE	16	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	Roll-over Subjects	>=1 serious TEAE	9	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	De Novo Subjects	>=1 serious study treatment-related TEAE	0	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	Roll-over Subjects	>=1 serious study treatment-related TEAE	0	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	De Novo Subjects	Death	0	Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period	Roll-over Subjects	Death	0	Participants

1 to 10 of 101Source ClinicalTrials.gov

See all 101 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run-In Period (Days -14 to Day -1)	STARTED	De Novo Subjects	508
Run-In Period (Days -14 to Day -1)	STARTED	Roll-over Subjects	267
Run-In Period (Days -14 to Day -1)	COMPLETED	De Novo Subjects	412
Run-In Period (Days -14 to Day -1)	COMPLETED	Roll-over Subjects	257
Run-In Period (Days -14 to Day -1)	NOT COMPLETED	De Novo Subjects	96
Run-In Period (Days -14 to Day -1)	NOT COMPLETED	Roll-over Subjects	10
Treatment Period	STARTED	De Novo Subjects	412
Treatment Period	STARTED	Roll-over Subjects	257
Treatment Period	COMPLETED	De Novo Subjects	206
Treatment Period	COMPLETED	Roll-over Subjects	200

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events68

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	De Novo Subjects	47	412
other	Constipation	Gastrointestinal disorders	Roll-over Subjects	9	257
other	Nausea	Gastrointestinal disorders	De Novo Subjects	37	412
other	Nausea	Gastrointestinal disorders	Roll-over Subjects	10	257
other	Injection site pain	General disorders	De Novo Subjects	39	412
other	Injection site pain	General disorders	Roll-over Subjects	7	257
other	Insomnia	Psychiatric disorders	De Novo Subjects	27	412
other	Insomnia	Psychiatric disorders	Roll-over Subjects	10	257
other	Headache	Nervous system disorders	De Novo Subjects	31	412
other	Headache	Nervous system disorders	Roll-over Subjects	5	257

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	De Novo Subjects	0	412
Total, all-cause mortality	Roll-over Subjects	0	257
Total, other adverse events	De Novo Subjects	146	412
Total, other adverse events	Roll-over Subjects	42	257
Total, serious adverse events	De Novo Subjects	16	412
Total, serious adverse events	Roll-over Subjects	9	257

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35287034	DERIVED	PubMed
37657559	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
De Novo Subjects vs Roll-over Subjects: deaths from any cause	Trial comparisons
De Novo Subjects vs Roll-over Subjects: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02510014

GET https://conductscience.org/api/trials/v1/NCT02510014/results?page=2

API reference For AI assistants