Trial · NCT01666119
An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
NCT01666119, Phase 2, Completed, BioDelivery Sciences International; results first posted 2017-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects. Trials, record NCT01666119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01666119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
- NCT number
- NCT01666119
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 249 participants, actual
- Lead sponsor
- BioDelivery Sciences International
- Conditions
- Opioid Dependence
- Interventions
- BEMA Buprenorphine NX films
- First posted
- 2012-08-16
- Last updated
- 2017-04-04
- Results first posted
- 2017-04-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | 12 weeks | Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in \> 2 subjects, the total number of unique events that were experienced are reported. |
| Secondary | Urine Drug Screen | 12 weeks | Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Urine Drug Screen | 12 weeks | Subjects with at least one urine drug screen test during the treatment period. | participants | NUMBER |
| PRIMARY | Adverse Events | 12 weeks | All subjects who received at least 1 dose of study drug. | adverse events | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urine Drug Screen | BEMA Buprenorphine/NX Films | Subjects with +-result for non-prescribed opiod | 19 | participants | |
| Urine Drug Screen | BEMA Buprenorphine/NX Films | Number with single positive result | 11 | participants | |
| Urine Drug Screen | BEMA Buprenorphine/NX Films | Number with 2 positive results | 4 | participants | |
| Urine Drug Screen | BEMA Buprenorphine/NX Films | Number with > 2 positive results | 4 | participants | |
| Adverse Events | BEMA Buprenorphine/NX Films | 36 | adverse events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BEMA Buprenorphine NX Films | 249 | |
| Overall Study | COMPLETED | BEMA Buprenorphine NX Films | 197 | |
| Overall Study | NOT COMPLETED | BEMA Buprenorphine NX Films | 52 |
Source ClinicalTrials.gov
Adverse events3
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 | drug withdrawal syndrome | General disorders | BEMA Buprenorphine NX Films | 89 | 249 | 89 |
| serious | osteomyelitis | Infections and infestations | BEMA Buprenorphine NX Films | 1 | 249 | 1 |
| serious | suicidal ideation | Psychiatric disorders | BEMA Buprenorphine NX Films | 1 | 249 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BEMA Buprenorphine NX Films | ||
| Total, other adverse events | BEMA Buprenorphine NX Films | 89 | 249 |
| Total, serious adverse events | BEMA Buprenorphine NX Films | 1 | 249 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25823919 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01666119
GET https://conductscience.org/api/trials/v1/NCT01666119/registered