Trial · NCT02672111
Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
NCT02672111, Phase 3, Completed, Braeburn Pharmaceuticals; results first posted 2019-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder. Trials, record NCT02672111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02672111
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
- NCT number
- NCT02672111
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 228 participants, actual
- Lead sponsor
- Braeburn Pharmaceuticals
- Conditions
- Opioid Use Disorder
- Interventions
- CAM2038 q1w or q4w exposure to SL BPN/NX, CAM2038 q1w or q4w new to BPN treatment
- First posted
- 2016-02-03
- Last updated
- 2020-05-15
- Results first posted
- 2019-08-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | 12 months- 48 week | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population |
| Primary | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population | 12 months- 48 week | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population |
| Secondary | Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population) | 12 months (48 weeks) | The following is a summary of Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population) |
| Secondary | Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population) | 12 months (48 weeks) | The following is a summary of Mean Percentage of Self-Reported No Illicit Opioid Use during the entire study (Efficacy Population). The proportion of patients who reported no illicit opioid use during the study was analyzed. For example if a subject provided 10 self reports and 2 out of the 10 were "Used", the percentage for the subject would be 20%. The average percentage of all patients is provided. |
| Secondary | Summary of Retention in Treatment (Efficacy Population) | 48 weeks of treatment | The following is a summary of treatment retention over 48 weeks |
| Secondary | Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | A summary of COWS (administered by the Clinician) over 48 weeks to show withdrawal symptoms from baseline to end of treatment. This scale consists of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale from 0 to 4 or 5 and based on a timed period of observation of the subject by the rater. Higher scores are associated with greater withdrawal symptoms with a total range for all items of between 0-48 |
| Secondary | Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | Summary of SOWS over time to show withdrawal symtons, from baseline to end of treatment. This form contains 16 questions that rate the intensity of withdrawal from 0 ("Not at all") to 4 ("Extremely"), with higher scores associated with greater withdrawal symptoms and total range for all items of 0-64 |
| Secondary | Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | The following table summarizes the desire to use measurements over a period of 12 months - 48 weeks. Desire to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest desire to use opioids, where 0 = No desire to use and 100 mm = Strongest possible desire. |
| Secondary | Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | The following results summarize the need to use VAS over a period of 12 months - 48 weeks. Need to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked "Since your last scheduled assessment visit, indicate your worst or strongest need to use opioids, where 0 = No need to use and 100 mm = Strongest possible need. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | 12 months- 48 week | Overall Safety Population-Subjects treated with CAM2038 | participants | NUMBER |
| PRIMARY | Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population | 12 months- 48 week | Full Exposure Safety Population-Subjects treated with CAM2038 | participants | NUMBER |
| SECONDARY | Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population) | 12 months (48 weeks) | Efficacy Population | percentage of negative urine samples | MEAN |
| SECONDARY | Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population) | 12 months (48 weeks) | Efficacy Population | Mean percentage of no illicit opioid use | MEAN |
| SECONDARY | Summary of Retention in Treatment (Efficacy Population) | 48 weeks of treatment | Efficacy Population | weeks | MEAN |
| SECONDARY | Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | Efficacy Population | score on a scale | MEAN |
| SECONDARY | Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | Efficacy Population | score on a scale | MEAN |
| SECONDARY | Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | Efficacy Population | score on a scale | MEAN |
| SECONDARY | Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population) | 12 months- 48 week | Efficacy Population | score 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 |
|---|---|---|---|---|---|
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | Subject had at least 1 TEAE | 131 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w New to BPN Treatment | Subject had at least 1 TEAE | 12 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | Subject had at least 1 drug-related TEAE | 58 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w New to BPN Treatment | Subject had at least 1 drug-related TEAE | 2 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | Subject had at least 1 severe TEAE | 13 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w New to BPN Treatment | Subject had at least 1 severe TEAE | 2 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | Deaths | 0 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w New to BPN Treatment | Deaths | 0 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | Subject had at least 1 non-fatal SAE | 10 | participants | |
| Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population | CAM2038 q1w or q4w New to BPN Treatment | Subject had at least 1 non-fatal SAE | 2 | participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 190 | |
| Overall Study | STARTED | CAM2038 q1w or q4w New to BPN Treatment | 37 | |
| Overall Study | Completed Treatment | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 138 | |
| Overall Study | Completed Treatment | CAM2038 q1w or q4w New to BPN Treatment | 29 | |
| Overall Study | COMPLETED | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 132 | |
| Overall Study | COMPLETED | CAM2038 q1w or q4w New to BPN Treatment | 25 | |
| Overall Study | NOT COMPLETED | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 58 | |
| Overall Study | NOT COMPLETED | CAM2038 q1w or q4w New to BPN Treatment | 12 |
Source ClinicalTrials.gov
Adverse events48
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 | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 33 | 190 | 33 |
| other | Injection site Pain | General disorders | CAM2038 q1w or q4w New to BPN Treatment | 2 | 37 | 2 |
| other | Injection SIte Swelling | General disorders | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 25 | 190 | 25 |
| other | Injection SIte Swelling | General disorders | CAM2038 q1w or q4w New to BPN Treatment | 2 | 37 | 2 |
| other | Injection site erythema | General disorders | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 20 | 190 | 20 |
| other | Injection site erythema | General disorders | CAM2038 q1w or q4w New to BPN Treatment | 1 | 37 | 1 |
| other | Nausea | Gastrointestinal disorders | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 16 | 190 | 16 |
| other | Nausea | Gastrointestinal disorders | CAM2038 q1w or q4w New to BPN Treatment | 0 | 37 | 0 |
| other | Headache | Nervous system disorders | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 18 | 190 | 18 |
| other | Headache | Nervous system disorders | CAM2038 q1w or q4w New to BPN Treatment | 0 | 37 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 0 | 190 |
| Total, all-cause mortality | CAM2038 q1w or q4w New to BPN Treatment | 0 | 37 |
| Total, other adverse events | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 131 | 190 |
| Total, other adverse events | CAM2038 q1w or q4w New to BPN Treatment | 11 | 37 |
| Total, serious adverse events | CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX | 13 | 190 |
| Total, serious adverse events | CAM2038 q1w or q4w New to BPN Treatment | 2 | 37 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31013390 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX vs CAM2038 q1w or q4w New to BPN Treatment: deaths from any cause | Trial comparisons |
| CAM2038 q1w or q4w With Prior Exposure to SL BPN/NX vs CAM2038 q1w or q4w New to BPN Treatment: 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/NCT02672111
GET https://conductscience.org/api/trials/v1/NCT02672111/results?page=2