Trial · NCT01848054
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
NCT01848054, Phase 3, Completed, Orexo AB; results first posted 2015-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence. Trials, record NCT01848054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01848054
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
- NCT number
- NCT01848054
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 313 participants, actual
- Lead sponsor
- Orexo AB
- Conditions
- Opioid-Related Disorders, Opiate Dependence
- Interventions
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- First posted
- 2013-05-07
- Last updated
- 2017-05-10
- Results first posted
- 2015-06-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Retention in Treatment in the Per Protocol Population | Day 3 | Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3. |
| Secondary | Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive | Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1 | Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable |
| Secondary | AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive | Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1 | Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable |
| Secondary | AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive | Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1 | Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had") |
| Secondary | Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase) | Predose on Days 4, 8, 15, 22, and 29 | Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable |
| Secondary | Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase) | Pre-dose on Days 4, 8, 15, 22, and 29 | Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable |
| Secondary | Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase) | Pre-dose on Days 4, 8, 15, 22, and 29 | Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had") |
| Secondary | Retention in Treatment in the Full Analysis Population | Day 3 | Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3. |
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 | Retention in Treatment in the Per Protocol Population | Day 3 | Per protocol population | participants | NUMBER |
| SECONDARY | Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive | Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1 | Full analysis population | score x hour | LEAST_SQUARES_MEAN |
| SECONDARY | AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive | Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1 | Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed | score x hour | LEAST_SQUARES_MEAN |
| SECONDARY | AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive | Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1 | Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed | score x hour | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase) | Predose on Days 4, 8, 15, 22, and 29 | Full analysis population; patients with missing data were excluded from the analysis | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase) | Pre-dose on Days 4, 8, 15, 22, and 29 | Full analysis population; patients with missing data were excluded from the analysis | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase) | Pre-dose on Days 4, 8, 15, 22, and 29 | Full analysis population; patients with missing data were excluded from the analysis | units on a scale | MEAN |
| SECONDARY | Retention in Treatment in the Full Analysis Population | Day 3 | Full analysis population; patients with missing data were excluded from the analysis | participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Retention in Treatment in the Per Protocol Population | BNX Sublingual Tablets Induction | 113 | participants | ||
| Retention in Treatment in the Per Protocol Population | Buprenorphine Induction | 122 | participants | ||
| Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive | BNX Sublingual Tablets Induction | 7.21 | Standard Deviation 4.3 | score x hour | |
| Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive | Buprenorphine Induction | 6.88 | Standard Deviation 4.0 | score x hour | |
| AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive | BNX Sublingual Tablets Induction | 17.7 | Standard Deviation 13.5 | score x hour | |
| AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive | Buprenorphine Induction | 17.4 | Standard Deviation 12.8 | score x hour | |
| AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive | BNX Sublingual Tablets Induction | 40.0 | Standard Deviation 25.3 | score x hour | |
| AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive | Buprenorphine Induction | 39.5 | Standard Deviation 24.7 | score x hour | |
| Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase) | BNX Sublingual Tablets Induction | Day 4 | -9.4 | Standard Deviation 5.8 | units on a scale |
| Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase) | Buprenorphine Induction | Day 4 | -8.5 | Standard Deviation 5.7 | units on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase | STARTED | BNX Sublingual Tablets Induction | 155 | |
| Induction Phase | STARTED | Buprenorphine Induction | 155 | |
| Induction Phase | COMPLETED | BNX Sublingual Tablets Induction | 132 | |
| Induction Phase | COMPLETED | Buprenorphine Induction | 147 | |
| Induction Phase | NOT COMPLETED | BNX Sublingual Tablets Induction | 23 | |
| Induction Phase | NOT COMPLETED | Buprenorphine Induction | 8 | |
| Stabilization/Maintenance | STARTED | BNX Sublingual Tablets Induction | 132 | |
| Stabilization/Maintenance | STARTED | Buprenorphine Induction | 147 | |
| Stabilization/Maintenance | COMPLETED | BNX Sublingual Tablets Induction | 92 | |
| Stabilization/Maintenance | COMPLETED | Buprenorphine Induction | 107 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events14
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 | Events |
|---|---|---|---|---|---|---|
| other | Nausea (Induction) | Gastrointestinal disorders | BNX Sublingual Tablets Induction | 12 | 155 | 12 |
| other | Nausea (Induction) | Gastrointestinal disorders | Buprenorphine Induction | 13 | 155 | 13 |
| other | Headache (Induction) | Nervous system disorders | BNX Sublingual Tablets Induction | 11 | 155 | 11 |
| other | Headache (Induction) | Nervous system disorders | Buprenorphine Induction | 11 | 155 | 11 |
| other | Insomnia (Induction) | Psychiatric disorders | BNX Sublingual Tablets Induction | 6 | 155 | 6 |
| other | Insomnia (Induction) | Psychiatric disorders | Buprenorphine Induction | 11 | 155 | 11 |
| other | Vomiting (Induction) | Gastrointestinal disorders | BNX Sublingual Tablets Induction | 8 | 155 | 8 |
| other | Vomiting (Induction) | Gastrointestinal disorders | Buprenorphine Induction | 8 | 155 | 8 |
| serious | Diabetic ketoacidosis | Blood and lymphatic system disorders | BNX Sublingual Tablets Induction | 1 | 155 | 1 |
| serious | Diabetic ketoacidosis | Blood and lymphatic system disorders | Buprenorphine Induction | 0 | 155 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BNX Sublingual Tablets Induction | ||
| Total, all-cause mortality | Buprenorphine Induction | ||
| Total, other adverse events | BNX Sublingual Tablets Induction | 37 | 155 |
| Total, other adverse events | Buprenorphine Induction | 43 | 155 |
| Total, serious adverse events | BNX Sublingual Tablets Induction | 1 | 155 |
| Total, serious adverse events | Buprenorphine Induction | 2 | 155 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BNX Sublingual Tablets Induction vs Buprenorphine Induction: Retention in Treatment in the Per Protocol Population | Trial comparisons |
| BNX Sublingual Tablets Induction vs Buprenorphine Induction: Retention in Treatment in the Full Analysis Population | Trial comparisons |
| BNX Sublingual Tablets Induction vs Buprenorphine Induction: 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.
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/NCT01848054
GET https://conductscience.org/api/trials/v1/NCT01848054/results?page=2