Trial · NCT04018664
Oral Abuse Potential Study of Nalbuphine
NCT04018664, Phase 1, Completed, Trevi Therapeutics; results first posted 2020-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Abuse Potential Study of Nalbuphine. Trials, record NCT04018664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04018664
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Abuse Potential Study of Nalbuphine
- NCT number
- NCT04018664
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 56 participants, actual
- Lead sponsor
- Trevi Therapeutics
- Conditions
- Nalbuphine, Opioid Abuse
- Interventions
- Nalbuphine HCl solution, Placebo solution
- First posted
- 2019-07-12
- Last updated
- 2025-05-21
- Results first posted
- 2020-08-31
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose | Only Part A of thie study was conducted because of closure the clinical research unit (CRU) before Part B could be initiated. Summary statistics are provided for C-max |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose | C max | microgram/L | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | 90 mg Nalbuphine HCl Solution | 21.70 | Standard Deviation 6.65 | microgram/L | |
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | 120 mg Nalbuphine HCl Solution | 51.90 | Standard Deviation 26.89 | microgram/L | |
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | 150 mg Nalbuphine HCl Solution | 68.67 | Standard Deviation 30.19 | microgram/L | |
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | 180 mg Nalbuphine HCl Solution | 76.60 | Standard Deviation 51.34 | microgram/L | |
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | 270 mg Nalbuphine HCl Solution | 56.00 | Standard Deviation 6.09 | microgram/L | |
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | Up to 405 mg Nalbuphine HCl Solution | 158.55 | Standard Deviation 115.65 | microgram/L | |
| To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). | Up to 540 mg Nalbuphine HCl Solution | 196.83 | Standard Deviation 92.34 | microgram/L |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | STARTED | 90 mg Nalbuphine HCl Solution | 6 | |
| Overall Study | STARTED | 120 mg Nalbuphine HCl Solution | 6 | |
| Overall Study | STARTED | 150 mg Nalbuphine HCl Solution | 6 | |
| Overall Study | STARTED | 180 mg Nalbuphine HCl Solution | 6 | |
| Overall Study | STARTED | 270 mg Nalbuphine HCl Solution | 6 | |
| Overall Study | STARTED | Up to 405 mg Nalbuphine HCl Solution | 6 | |
| Overall Study | STARTED | Up to 540 mg Nalbuphine HCl Solution | 6 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | COMPLETED | 90 mg Nalbuphine HCl Solution | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, all-cause mortality | 90 mg Nalbuphine HCl Solution | 0 | 6 |
| Total, all-cause mortality | 120 mg Nalbuphine HCl Solution | 0 | 6 |
| Total, all-cause mortality | 150 mg Nalbuphine HCl Solution | 0 | 6 |
| Total, all-cause mortality | 180 mg Nalbuphine HCl Solution | 0 | 6 |
| Total, all-cause mortality | 270 mg Nalbuphine HCl Solution | 0 | 6 |
| Total, all-cause mortality | Up to 405 mg Nalbuphine HCl Solution | 0 | 6 |
| Total, all-cause mortality | Up to 540 mg Nalbuphine HCl Solution | 0 | 6 |
| Total, other adverse events | Placebo | 0 | 14 |
| Total, other adverse events | 90 mg Nalbuphine HCl Solution | 0 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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.
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/NCT04018664
GET https://conductscience.org/api/trials/v1/NCT04018664/flow?page=2