Trial · NCT02180659
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
NCT02180659, Phase 3, Completed, Titan Pharmaceuticals; results first posted 2018-12-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants. Trials, record NCT02180659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02180659
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
- NCT number
- NCT02180659
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 177 participants, actual
- Lead sponsor
- Titan Pharmaceuticals
- Conditions
- Opioid Dependence
- Interventions
- sublingual buprenorphine tablets, Buprenorphine implant, placebo implants, sublingual placebo tablets
- First posted
- 2014-07-03
- Last updated
- 2019-01-11
- Results first posted
- 2018-12-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use. | 24 weeks | The primary efficacy endpoint is a responder analysis. A subject will be designated as a responder (meaning they have maintained stability) if they have no more than 2 of 6 months with any evidence of illicit opioid use. Evidence of illicit opioid use is defined as a positive opioid urine toxicology result or self-reported illicit opioid use. |
| Secondary | Percent of Subjects With no Urine Illicit Opioid Use by Month; | 24 weeks | The secondary outcome is the percent of subjects with no urine illicit opioid use by month. |
| Secondary | Number of Participants With Evidence of Urine Illicit Opioid Use by Month | 24 weeks | Secondary efficacy endpoint measures number of participants with evidence of urine illicit opioid use by month. |
| Secondary | Percent of Subjects With no Self-reported Illicit Drug Use by Month | 24 weeks | Subjects in the ITT population with no self-reported use of any illicit drugs (opioid or non-opioid) by month of evaluation |
| Secondary | Measures of Craving: Desire to Use Visual Analogue Scale (VAS) | 24 weeks | The secondary outcome of measures of craving: desire to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no desire, and 100 mm is strongest possible desire. |
| Secondary | Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS) | 24 weeks | The secondary outcome measures the change in baseline in the Clinical opiate withdrawal scale (COWS), which is a scale consisting of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale with higher scores associated with greater withdrawal symptoms. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: 0-4=none/normal, 5-12=mild, 13-24=moderate, 25-36=moderately severe, more than 36=severe withdrawal. |
| Secondary | Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population) | 24 weeks | The secondary outcome measures the change in baseline in the subjective opioid withdrawal scale (SOWS), which is a scale which is a subject self-assessment of withdrawal symptoms. The scale consists of 16 questions that rate the intensity of withdrawal from 0 (not at all) to 4 (extremely) with a cumulative score ranging from 0-64 (0 =not at all, 64=extremely) |
| Secondary | Measures of Craving: Need to Use Visual Analogue Scale (VAS) | 24 weeks | The secondary outcome of measures of craving: Need to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no need, and 100 mm is strongest possible need. |
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 | The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use. | 24 weeks | The analyses included 173 subjects in the ITT population who received treatment and post-baseline evaluations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Subjects With no Urine Illicit Opioid Use by Month; | 24 weeks | Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Evidence of Urine Illicit Opioid Use by Month | 24 weeks | Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Subjects With no Self-reported Illicit Drug Use by Month | 24 weeks | Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Measures of Craving: Desire to Use Visual Analogue Scale (VAS) | 24 weeks | Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above. | units on a scale | MEAN |
| SECONDARY | Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS) | 24 weeks | Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above. | units on a scale | MEAN |
| SECONDARY | Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population) | 24 weeks | Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above. | units on a scale | MEAN |
| SECONDARY | Measures of Craving: Need to Use Visual Analogue Scale (VAS) | 24 weeks | Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use. | Buprenorphine Implants + Placebo Tablets | Responder | 81 | Participants | |
| The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use. | Buprenorphine Tablets + Placebo Implants | Responder | 78 | Participants | |
| The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use. | Buprenorphine Implants + Placebo Tablets | Non-Responder | 3 | Participants | |
| The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use. | Buprenorphine Tablets + Placebo Implants | Non-Responder | 11 | Participants | |
| Percent of Subjects With no Urine Illicit Opioid Use by Month; | Buprenorphine Implants + Placebo Tablets | Month 1 / Yes | 80 | Participants | |
| Percent of Subjects With no Urine Illicit Opioid Use by Month; | Buprenorphine Tablets + Placebo Implants | Month 1 / Yes | 84 | Participants | |
| Percent of Subjects With no Urine Illicit Opioid Use by Month; | Buprenorphine Implants + Placebo Tablets | Month 1 / No | 4 | Participants | |
| Percent of Subjects With no Urine Illicit Opioid Use by Month; | Buprenorphine Tablets + Placebo Implants | Month 1 / No | 5 | Participants | |
| Percent of Subjects With no Urine Illicit Opioid Use by Month; | Buprenorphine Implants + Placebo Tablets | Month 2 / Yes | 80 | Participants | |
| Percent of Subjects With no Urine Illicit Opioid Use by Month; | Buprenorphine Tablets + Placebo Implants | Month 2 / Yes | 79 | Participants |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buprenorphine Implants + Placebo Tablets | 87 | |
| Overall Study | STARTED | Buprenorphine Tablets + Placebo Implants | 89 | |
| Overall Study | COMPLETED | Buprenorphine Implants + Placebo Tablets | 81 | |
| Overall Study | COMPLETED | Buprenorphine Tablets + Placebo Implants | 84 | |
| Overall Study | NOT COMPLETED | Buprenorphine Implants + Placebo Tablets | 6 | |
| Overall Study | NOT COMPLETED | Buprenorphine Tablets + Placebo Implants | 5 |
Source ClinicalTrials.gov
Adverse events20
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 | Muscle spasm | Musculoskeletal and connective tissue disorders | Buprenorphine Implants + Placebo Tablets | 1 | 87 | 1 |
| other | Muscle spasm | Musculoskeletal and connective tissue disorders | Buprenorphine Tablets + Placebo Implants | 0 | 89 | 0 |
| other | Abortion - Spontaneous | Pregnancy, puerperium and perinatal conditions | Buprenorphine Implants + Placebo Tablets | 0 | 87 | 0 |
| other | Abortion - Spontaneous | Pregnancy, puerperium and perinatal conditions | Buprenorphine Tablets + Placebo Implants | 1 | 89 | 1 |
| other | Pregnancy | Pregnancy, puerperium and perinatal conditions | Buprenorphine Implants + Placebo Tablets | 0 | 87 | 0 |
| other | Pregnancy | Pregnancy, puerperium and perinatal conditions | Buprenorphine Tablets + Placebo Implants | 1 | 89 | 1 |
| other | Pediatric exposure to treatment | Pregnancy, puerperium and perinatal conditions | Buprenorphine Implants + Placebo Tablets | 0 | 87 | 0 |
| other | Pediatric exposure to treatment | Pregnancy, puerperium and perinatal conditions | Buprenorphine Tablets + Placebo Implants | 1 | 89 | 1 |
| other | Cellulitis | Skin and subcutaneous tissue disorders | Buprenorphine Implants + Placebo Tablets | 0 | 87 | 0 |
| other | Cellulitis | Skin and subcutaneous tissue disorders | Buprenorphine Tablets + Placebo Implants | 1 | 89 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buprenorphine Implants + Placebo Tablets | ||
| Total, all-cause mortality | Buprenorphine Tablets + Placebo Implants | ||
| Total, other adverse events | Buprenorphine Implants + Placebo Tablets | 1 | 87 |
| Total, other adverse events | Buprenorphine Tablets + Placebo Implants | 4 | 89 |
| Total, serious adverse events | Buprenorphine Implants + Placebo Tablets | 2 | 87 |
| Total, serious adverse events | Buprenorphine Tablets + Placebo Implants | 3 | 89 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27434441 | 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 |
|---|
| Buprenorphine Implants + Placebo Tablets vs Buprenorphine Tablets + Placebo Implants: 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.
GET https://conductscience.org/api/trials/v1/NCT02180659
GET https://conductscience.org/api/trials/v1/NCT02180659/results?page=2