Trial · NCT04828005
Pharmacodynamic Evaluation of Intranasal Nalmefene
NCT04828005, Phase 1, Completed, Opiant Pharmaceuticals Inc; results first posted 2025-07-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacodynamic Evaluation of Intranasal Nalmefene. Trials, record NCT04828005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04828005
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacodynamic Evaluation of Intranasal Nalmefene
- NCT number
- NCT04828005
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 84 participants, actual
- Lead sponsor
- Opiant Pharmaceuticals Inc
- Conditions
- Pharmacodynamic
- Interventions
- Nalmefene hydrochloride, Naloxone hydrochloride
- First posted
- 2021-04-01
- Last updated
- 2025-07-14
- Results first posted
- 2025-07-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Minute Ventilation | 5 minutes | Change in minute ventilation from opioid induced nadir |
| Secondary | Maximum Change in Minute Ventilation | Up to 2 hours | Maximum change in minute ventilation from opioid induced nadir |
| Secondary | Time to Maximum Change in Minute Ventilation | Up to 2 hours | Time to maximum change in minute ventilation from opioid induced nadir |
| Secondary | Change in Minute Ventilation | 90 minutes | Change in minute ventilation from opioid induced nadir |
| Secondary | Change in Minute Ventilation | 20 minutes | Change in minute ventilation from opioid induced nadir |
| Secondary | Change in Minute Ventilation | 15 minutes | Change in minute ventilation from opioid induced nadir |
| Secondary | Change in Minute Ventilation | 10 minutes | Change in minute ventilation from opioid induced nadir |
| Secondary | Change in Minute Ventilation | 2.5 minutes | Change in minute ventilation from opioid induced nadir |
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 | Change in Minute Ventilation | 5 minutes | L/min | MEAN | |
| SECONDARY | Maximum Change in Minute Ventilation | Up to 2 hours | ng/mL | MEAN | |
| SECONDARY | Time to Maximum Change in Minute Ventilation | Up to 2 hours | hour | MEDIAN | |
| SECONDARY | Change in Minute Ventilation | 90 minutes | L/min | MEAN | |
| SECONDARY | Change in Minute Ventilation | 20 minutes | L/min | MEAN | |
| SECONDARY | Change in Minute Ventilation | 15 minutes | L/min | MEAN | |
| SECONDARY | Change in Minute Ventilation | 10 minutes | L/min | MEAN | |
| SECONDARY | Change in Minute Ventilation | 2.5 minutes | L/min | MEAN |
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 |
|---|---|---|---|---|---|
| Change in Minute Ventilation | Intranasal Naloxone | 3.432 | Standard Error 0.6117 | L/min | |
| Change in Minute Ventilation | Intranasal Nalmefene | 5.744 | Standard Error 0.6240 | L/min | |
| Maximum Change in Minute Ventilation | Intranasal Nalmefene | 6.8 | Standard Deviation 2.7 | ng/mL | |
| Maximum Change in Minute Ventilation | Intranasal Naloxone | 5.8 | Standard Deviation 3.0 | ng/mL | |
| Time to Maximum Change in Minute Ventilation | Intranasal Nalmefene | 0.50 | Full Range 0.04 to 2.00 | hour | |
| Time to Maximum Change in Minute Ventilation | Intranasal Naloxone | 0.75 | Full Range 0.13 to 2.00 | hour | |
| Change in Minute Ventilation | Intranasal Nalmefene | 2.71 | Standard Error 0.59 | L/min | |
| Change in Minute Ventilation | Intranasal Naloxone | 2.14 | Standard Error 0.62 | L/min | |
| Change in Minute Ventilation | Intranasal Nalmefene | 6.79 | Standard Error 0.71 | L/min | |
| Change in Minute Ventilation | Intranasal Naloxone | 5.93 | Standard Error 0.68 | L/min |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 Setup: 1st Treatment (1 Day) | STARTED | Part 1 Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone | 7 | |
| Part 1 Setup: 1st Treatment (1 Day) | STARTED | Part 1 Extension Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone | 0 | |
| Part 1 Setup: 1st Treatment (1 Day) | STARTED | Part 2: Intranasal Nalmefene Crossover to Intranasal Naloxone | 0 | |
| Part 1 Setup: 1st Treatment (1 Day) | STARTED | Part 2: Intranasal Naloxone Crossover to Intranasal Nalmefene | 0 | |
| Part 1 Setup: 1st Treatment (1 Day) | COMPLETED | Part 1 Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone | 7 | |
| Part 1 Setup: 1st Treatment (1 Day) | COMPLETED | Part 1 Extension Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone | 0 | |
| Part 1 Setup: 1st Treatment (1 Day) | COMPLETED | Part 2: Intranasal Nalmefene Crossover to Intranasal Naloxone | 0 | |
| Part 1 Setup: 1st Treatment (1 Day) | COMPLETED | Part 2: Intranasal Naloxone Crossover to Intranasal Nalmefene | 0 | |
| Part 1 Setup: 1st Treatment (1 Day) | NOT COMPLETED | Part 1 Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone | 0 | |
| Part 1 Setup: 1st Treatment (1 Day) | NOT COMPLETED | Part 1 Extension Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events26
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 | Nausea | Gastrointestinal disorders | Intranasal Nalmefene | 24 | 61 | |
| other | Nausea | Gastrointestinal disorders | Intranasal Naloxone | 25 | 60 | |
| other | Vomiting | Gastrointestinal disorders | Intranasal Nalmefene | 7 | 61 | |
| other | Vomiting | Gastrointestinal disorders | Intranasal Naloxone | 14 | 60 | |
| other | Dry Mouth | Gastrointestinal disorders | Intranasal Nalmefene | 4 | 61 | |
| other | Dry Mouth | Gastrointestinal disorders | Intranasal Naloxone | 0 | 60 | |
| other | Fatigue | General disorders | Intranasal Nalmefene | 6 | 61 | |
| other | Fatigue | General disorders | Intranasal Naloxone | 2 | 60 | |
| other | Headache | Nervous system disorders | Intranasal Nalmefene | 36 | 61 | |
| other | Headache | Nervous system disorders | Intranasal Naloxone | 35 | 60 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intranasal Nalmefene | 0 | 61 |
| Total, all-cause mortality | Intranasal Naloxone | 0 | 60 |
| Total, other adverse events | Intranasal Nalmefene | 56 | 61 |
| Total, other adverse events | Intranasal Naloxone | 52 | 60 |
| Total, serious adverse events | Intranasal Nalmefene | 0 | 61 |
| Total, serious adverse events | Intranasal Naloxone | 0 | 60 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intranasal Nalmefene vs Intranasal Naloxone: deaths from any cause | Trial comparisons |
| Intranasal Nalmefene vs Intranasal Naloxone: 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/NCT04828005
GET https://conductscience.org/api/trials/v1/NCT04828005/flow?page=2