Trial · NCT01908842
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
NCT01908842, Phase 3, Completed, Orexo AB; results first posted 2015-05-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults. Trials, record NCT01908842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01908842
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
- NCT number
- NCT01908842
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 759 participants, actual
- Lead sponsor
- Orexo AB
- Conditions
- Opioid Dependence, on Agonist Therapy
- Interventions
- BNX sublingual tablets, BNX sublingual film, Buprenorphine
- First posted
- 2013-07-26
- Last updated
- 2017-05-10
- Results first posted
- 2015-05-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Endpoints of Retention in Treatment at Days 3 and 15 | Day 3 and Day 15 | Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15. |
| Secondary | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Days 1 and 2 | Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable |
| Secondary | COWS Total Scores: Stabilization/Maintenance | Days 3 through 22 | Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable |
| Secondary | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Days 1 and 2 | Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable |
| Secondary | SOWS Total Scores: Stabilization/Maintenance | Days 3 through 22 | Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable |
| Secondary | Visual Analog Scale (VAS) Cravings: Induction | Days 1 and 2 | Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had") |
| Secondary | VAS Craving Scores: Stabilization/Maintenance | Days 3 through 22 | Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had") |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Days 1 and 2 | Full Analysis Population - number of enrolled patients at the beginning of the measurement period | units on a scale | MEAN |
| SECONDARY | COWS Total Scores: Stabilization/Maintenance | Days 3 through 22 | Full analysis population - - number of enrolled patients at the beginning of the measurement period | units on a scale | MEAN |
| SECONDARY | Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction | Days 1 and 2 | Full analysis population - number of enrolled patients at the beginning of the measurement period | units on a scale | MEAN |
| PRIMARY | Primary Endpoints of Retention in Treatment at Days 3 and 15 | Day 3 and Day 15 | Per protocol population | participants | NUMBER |
| SECONDARY | SOWS Total Scores: Stabilization/Maintenance | Days 3 through 22 | Full Analysis Population - number of enrolled patients at the beginning of the measurement period | units on a scale | MEAN |
| SECONDARY | Visual Analog Scale (VAS) Cravings: Induction | Days 1 and 2 | Full Analysis Population - number of enrolled patients at the beginning of the measurement period | units on a scale | MEAN |
| SECONDARY | VAS Craving Scores: Stabilization/Maintenance | Days 3 through 22 | Full analysis population - number of enrolled patients at the beginning of the measurement period | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | BNX Tablets, Then OL BNX Tablets, Then BNX Film | Baseline | 15.0 | Standard Deviation 4.2 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Buprenorphine, Then OL BNX Film, Then BNX Tablets | Baseline | 14.9 | Standard Deviation 4.3 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | BNX Tablets, Then OL BNX Tablets, Then BNX Film | Day 1 0.5 h post dose | 10.5 | Standard Deviation 4.6 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Buprenorphine, Then OL BNX Film, Then BNX Tablets | Day 1 0.5 h post dose | 10.3 | Standard Deviation 4.7 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | BNX Tablets, Then OL BNX Tablets, Then BNX Film | Day 1 1.5 h post dose | 8.8 | Standard Deviation 4.6 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Buprenorphine, Then OL BNX Film, Then BNX Tablets | Day 1 1.5 h post dose | 8.3 | Standard Deviation 4.5 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | BNX Tablets, Then OL BNX Tablets, Then BNX Film | Day 1 3 h post dose | 6.6 | Standard Deviation 5.1 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Buprenorphine, Then OL BNX Film, Then BNX Tablets | Day 1 3 h post dose | 6.1 | Standard Deviation 5.1 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | BNX Tablets, Then OL BNX Tablets, Then BNX Film | Day 1 6 h post dose | 5.3 | Standard Deviation 4.1 | units on a scale |
| Clinical Opiate Withdrawal Scale (COWS) Scores: Induction | Buprenorphine, Then OL BNX Film, Then BNX Tablets | Day 1 6 h post dose | 5.4 | Standard Deviation 4.6 | units on a scale |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 383 | |
| Induction | STARTED | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 375 | |
| Induction | COMPLETED | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 357 | |
| Induction | COMPLETED | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 344 | |
| Induction | NOT COMPLETED | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 26 | |
| Induction | NOT COMPLETED | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 31 | |
| Switch to Other BNX Formulation (Day 15) | STARTED | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 357 | |
| Switch to Other BNX Formulation (Day 15) | STARTED | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 344 | |
| Switch to Other BNX Formulation (Day 15) | COMPLETED | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 287 | |
| Switch to Other BNX Formulation (Day 15) | COMPLETED | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 279 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events22
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 | Headache | Nervous system disorders | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 20 | 383 | 20 |
| other | Headache | Nervous system disorders | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 19 | 375 | 19 |
| other | Vomiting | Gastrointestinal disorders | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 12 | 383 | 12 |
| other | Vomiting | Gastrointestinal disorders | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 11 | 375 | 11 |
| other | Nausea | Gastrointestinal disorders | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 8 | 383 | 8 |
| other | Nausea | Gastrointestinal disorders | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 15 | 375 | 15 |
| other | Dry mouth | Gastrointestinal disorders | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 8 | 383 | 8 |
| other | Dry mouth | Gastrointestinal disorders | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 2 | 375 | 2 |
| other | Insomnia | Psychiatric disorders | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 5 | 383 | 5 |
| other | Insomnia | Psychiatric disorders | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 4 | 375 | 4 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BNX Tablets, Then OL BNX Tablets, Then BNX Film | ||
| Total, all-cause mortality | Buprenorphine, Then OL BNX Film, Then BNX Tablets | ||
| Total, other adverse events | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 61 | 383 |
| Total, other adverse events | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 55 | 375 |
| Total, serious adverse events | BNX Tablets, Then OL BNX Tablets, Then BNX Film | 3 | 383 |
| Total, serious adverse events | Buprenorphine, Then OL BNX Film, Then BNX Tablets | 1 | 375 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26412801 | DERIVED |
Source 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BNX Tablets, Then OL BNX Tablets, Then BNX Film vs Buprenorphine, Then OL BNX Film, Then BNX Tablets: serious adverse events |
Source 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.
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