Trial · NCT06441604
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
NCT06441604, Phase 2, Active not recruiting, Brigham and Women's Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Extended-release Buprenorphine as a Novel Low-dose Induction Strategy. Trials, record NCT06441604. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06441604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
- NCT number
- NCT06441604
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Opioid Use Disorder
- Interventions
- Extended-release Buprenorphine
- First posted
- 2024-06-04
- Last updated
- 2026-07-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of XR-Buprenorphine | For the duration of the inpatient admission, lasting 24 hours after receipt of study drug. | The primary outcome is the proportion of participants who successfully complete induction, defined as experiencing no BPOW, which will be assessed using the COWS. An increase in the COWS score by 8 or more with the total score exceeding 13, within 4 hours will be considered BPOW. |
| Primary | Plasma-concentration curves (AUC) of buprenorphine. | Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration. | The area under the plasma concentration curves (AUC) of buprenorphine will be determined. Timed blood samples will be collected in anticoagulant Vacutainer tubes via venipuncture at baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after the XR-BUP injection. Samples will be centrifuged and frozen until analysis. |
| Secondary | Maximum Plasma Concentration | Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration. | Plasma data will be used to calculate maximum plasma concentration (Cmax) for buprenorphine, norbuprenorphine, and their glucuronides. |
| Secondary | Minimum Plasma Concentration (Cmin), | Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration. | Plasma data will be used to calculate minimum plasma concentration (Cmin) for buprenorphine, norbuprenorphine, and their glucuronides. |
| Secondary | Time to Maximum Plasma Concentration | Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration. | Plasma data will be used to calculate time to maximum plasma concentration (Tmax) for buprenorphine, norbuprenorphine, and their glucuronides. |
| Secondary | Elimination half-life | Baseline, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours after study drug administration. | Plasma data will be used to calculate elimination half-life (t1/2) for buprenorphine, norbuprenorphine, and their glucuronides. |
| Secondary | Buccal Swab | will be done once at the baseline visit. | DNA testing to check 3A4 activity levels. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06441604
GET https://conductscience.org/api/trials/v1/NCT06441604/registered