Trial · NCT02651584
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
NCT02651584, Phase 3, Completed, Braeburn Pharmaceuticals; results first posted 2019-08-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence. Trials, record NCT02651584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02651584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
- NCT number
- NCT02651584
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 428 participants, actual
- Lead sponsor
- Braeburn Pharmaceuticals
- Conditions
- Opioid Use Disorders
- Interventions
- CAM2038 SC injection, SL BPN/NX tabs, placebo SC injections, SL placebo tablets
- First posted
- 2016-01-11
- Last updated
- 2019-08-22
- Results first posted
- 2019-08-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate, Denoted by Response Rate (Weeks 1-24). | 24 weeks | Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use. |
| Secondary | Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids | 24 weeks | Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results) |
| Secondary | Number of Subjects With Sustained Abstinence of Opioid Use | 24 weeks | Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038 |
| Secondary | Number of Subjects Remaining in the Study (Retention Rate) | 24 weeks | Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate, Denoted by Response Rate (Weeks 1-24). | 24 weeks | Includes all subjects who were randomized and receiving at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids | 24 weeks | Includes all subjects who were randomized and receiving at least one dose of study drug. | percentage of negative urine samples | MEDIAN |
| SECONDARY | Number of Subjects With Sustained Abstinence of Opioid Use | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Remaining in the Study (Retention Rate) | 24 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate, Denoted by Response Rate (Weeks 1-24). | Group 1: SL BP/NX Tablets + Placebo SC Injections | Responder | 31 | Participants | |
| Response Rate, Denoted by Response Rate (Weeks 1-24). | Group 2: CAM2038 SC Injections + SL Placebo Tablets | Responder | 37 | Participants | |
| Response Rate, Denoted by Response Rate (Weeks 1-24). | Group 1: SL BP/NX Tablets + Placebo SC Injections | Non-Responder | 184 | Participants | |
| Response Rate, Denoted by Response Rate (Weeks 1-24). | Group 2: CAM2038 SC Injections + SL Placebo Tablets | Non-Responder | 176 | Participants | |
| Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids | SL BPN Tablets + Placebo Subcutaneous (SC) Injections | With Subjects' Self Reported Opioid Use | 0.0 | Full Range 0.0 to 100.0 | percentage of negative urine samples |
| Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids | Group 2: CAM2038 SC Injections + SL Placebo Tablets | With Subjects' Self Reported Opioid Use | 26.7 | Full Range 0.0 to 100.0 | percentage of negative urine samples |
| Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids | SL BPN Tablets + Placebo Subcutaneous (SC) Injections | Without Subjects' Self reported Opioid Use | 6.7 | Full Range 0.0 to 100.0 | percentage of negative urine samples |
| Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids | Group 2: CAM2038 SC Injections + SL Placebo Tablets | Without Subjects' Self reported Opioid Use | 26.7 | Full Range 0.0 to 100.0 | percentage of negative urine samples |
| Number of Subjects With Sustained Abstinence of Opioid Use | Group 1: SL BPN/NX Tabs+ Placebo Subcutaneous (SC) Injections | Subjects with sustained abstinence of opioids | 30 | Participants | |
| Number of Subjects With Sustained Abstinence of Opioid Use | Group 2: CAM2038 SC Injections + SL Placebo Tablets | Subjects with sustained abstinence of opioids | 39 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: SL BPN Tablets + Placebo Subcutaneous (SC) Injections | 215 | |
| Overall Study | STARTED | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 213 | |
| Overall Study | COMPLETED | Group 1: SL BPN Tablets + Placebo Subcutaneous (SC) Injections | 126 | |
| Overall Study | COMPLETED | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 121 | |
| Overall Study | NOT COMPLETED | Group 1: SL BPN Tablets + Placebo Subcutaneous (SC) Injections | 89 | |
| Overall Study | NOT COMPLETED | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 92 |
Source ClinicalTrials.gov
Adverse events84
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 | Injection site pain | General disorders | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 17 | 215 | 17 |
| other | Injection site pain | General disorders | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 19 | 213 | 19 |
| other | Injection site pruritus | General disorders | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 13 | 215 | 13 |
| other | Injection site pruritus | General disorders | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 13 | 213 | 13 |
| other | Injection site erythema | General disorders | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 12 | 215 | 12 |
| other | Injection site erythema | General disorders | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 12 | 213 | 12 |
| other | Injection site reaction | General disorders | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 7 | 215 | 7 |
| other | Injection site reaction | General disorders | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 8 | 213 | 8 |
| other | Injection site swelling | General disorders | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 6 | 215 | 6 |
| other | Injection site swelling | General disorders | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 9 | 213 | 9 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 0 | 215 |
| Total, all-cause mortality | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 1 | 213 |
| Total, other adverse events | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 119 | 215 |
| Total, other adverse events | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 128 | 213 |
| Total, serious adverse events | Group 1: SL BPN/NX Tablets + Placebo SC Injections | 16 | 215 |
| Total, serious adverse events | Group 2: CAM2038 SC Injections + SL Placebo Tablets | 5 | 213 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Group 1: SL BPN/NX Tablets + Placebo SC Injections vs Group 2: CAM2038 SC Injections + SL Placebo Tablets: deaths from any cause | Trial comparisons |
| Group 1: SL BPN/NX Tablets + Placebo SC Injections vs Group 2: CAM2038 SC Injections + SL Placebo Tablets: 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/NCT02651584
GET https://conductscience.org/api/trials/v1/NCT02651584/events?page=2