Trial · NCT04817410
ED Initiated Oral Naltrexone for AUD
NCT04817410, Phase 1, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2025-08-26
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. ED Initiated Oral Naltrexone for AUD. Trials, record NCT04817410. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04817410
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ED Initiated Oral Naltrexone for AUD
- NCT number
- NCT04817410
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Alcohol Use Disorder
- Interventions
- Emergency Department Initiated Oral Naltrexone
- First posted
- 2021-03-26
- Last updated
- 2025-08-26
- Results first posted
- 2025-08-26
- Limitations and caveats
- Due to the nonrandomized design, lack of a nontreatment control and small sample size, drawing inferences about efficacy of ED-initiated naltrexone on short-term engagement in care is not possible.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Day 14 | Number of participant enrolled with engagement in care of comprehensive addiction treatment |
| Primary | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Day 30 | Number of participant enrolled with engagement in care of comprehensive addiction treatment |
| Secondary | Number of Alcoholic Drinks Per Day | 7-days prior to enrollment to day of enrollment (baseline) | Baseline |
| Secondary | Number of Daily Drinks | 30-days | 30-days |
| Secondary | Daily Alcohol Craving Scale | up to 30 days | Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity. |
| Secondary | Guidelines Regimen Information Program (GRIP) Guide at Day 14 | Day 14 | Adherence to daily oral naltrexone measured using Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores mean better adherence. |
| Secondary | Guidelines Regimen Information Program (GRIP) Guide at Day 30 | Day 30 | Adherence to daily oral naltrexone measured using the Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores represent better adherence. |
| Secondary | Number of Pills in Bottle at Day 14 | Day 14 | Adherence to daily oral naltrexone measured using pill counts. |
| Secondary | Number of Pills in Bottle at Day 30 | Day 30 | Adherence to daily oral naltrexone measured using pill counts. |
| Secondary | Number of Heavy Drinking Days | up to 30 days | Number of heavy drinking days defined as 4 or more drinks for a woman or 5 or more drinks for a man on the same occasion in a 24 hour period. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Day 14 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Alcoholic Drinks Per Day | 7-days prior to enrollment to day of enrollment (baseline) | # of drinks consumed per day | MEDIAN | |
| SECONDARY | Number of Daily Drinks | 30-days | 30-days | # of drinks consumed per day | MEDIAN |
| SECONDARY | Daily Alcohol Craving Scale | up to 30 days | score on a scale | MEDIAN | |
| SECONDARY | Guidelines Regimen Information Program (GRIP) Guide at Day 14 | Day 14 | Adherence to daily oral naltrexone measured using Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores mean better adherence. | units on a scale | MEDIAN |
| SECONDARY | Guidelines Regimen Information Program (GRIP) Guide at Day 30 | Day 30 | Adherence to daily oral naltrexone measured using the Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores represent better adherence. | units on a scale | MEDIAN |
| SECONDARY | Number of Pills in Bottle at Day 14 | Day 14 | Pill count at day 14. Note: Participants did not return to clinic so pill counts were not collected. | ||
| SECONDARY | Number of Pills in Bottle at Day 30 | Day 30 | Pill counts at day 30 Note: Participants did not return to clinic so pill counts were not collected. | ||
| SECONDARY | Number of Heavy Drinking Days | up to 30 days | days | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Oral Naltrexone | Engaged in treatment at 14-days | 6 | Participants | |
| Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Oral Naltrexone | Not engaged in treatment at 14-days | 15 | Participants | |
| Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Enrolled Participant Characteristics | Engaged in treatment at 30-days | 7 | Participants | |
| Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Enrolled Participant Characteristics | Not engaged in treatment at 30-days | 14 | Participants | |
| Number of Alcoholic Drinks Per Day | Oral Naltrexone | 4.29 | Inter-Quartile Range 2.29 to 7.57 | # of drinks consumed per day | |
| Number of Daily Drinks | Enrolled Participant Characteristics | 0.73 | Inter-Quartile Range 0 to 2.81 | # of drinks consumed per day | |
| Daily Alcohol Craving Scale | Enrolled Participant Characteristics | 8.27 | Inter-Quartile Range 4.65 to 11.75 | score on a scale | |
| Guidelines Regimen Information Program (GRIP) Guide at Day 14 | Oral Naltrexone | 4.5 | Inter-Quartile Range 3 to 5 | units on a scale | |
| Guidelines Regimen Information Program (GRIP) Guide at Day 30 | Oral Naltrexone | 4 | Inter-Quartile Range 4 to 5 | units on a scale | |
| Number of Heavy Drinking Days | Oral Naltrexone | 0.0 | Inter-Quartile Range 0 to 0.17 | days |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Naloxone | 29 | |
| Overall Study | COMPLETED | Oral Naloxone | 21 | |
| Overall Study | NOT COMPLETED | Oral Naloxone | 8 |
Source ClinicalTrials.gov
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Naltrexone | 0 | 21 |
| Total, other adverse events | Oral Naltrexone | 0 | 21 |
| Total, serious adverse events | Oral Naltrexone | 0 | 21 |
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 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/NCT04817410
GET https://conductscience.org/api/trials/v1/NCT04817410/results?page=2