Trial · NCT04094584

Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder

NCT04094584, Phase 4, Terminated, University of California, San Francisco; results first posted 2023-06-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder. Trials, record NCT04094584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04094584

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
NCT number: NCT04094584
Status: Terminated
Phases: Phase 4
Enrollment: 179 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Alcohol Use Disorder, Substance Use, Alcohol Abuse or Dependence
Interventions: Vivitrol (Extended Release Naltrexone)
First posted: 2019-09-19
Last updated: 2023-06-22
Results first posted: 2023-06-22

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants Retained in Study at 3 Months	3 months	Percentage of enrolled participants who attend final study visit at the end of the intervention period
Primary	Retention at 12 Months	12 months	Percentage of enrolled participants who complete final study visit at the end of the follow up periods
Primary	Change in Daily Total Alcohol Consumption From Baseline at 3 Months	3 months after enrollment	Self-reported total daily alcohol consumption at 3 months, compared to baseline
Primary	Change in Total Alcohol Consumption at 12 Months	12 months after enrollment	Change in self-reported total daily alcohol consumption from baseline
Secondary	Change in Quality of Life Score at 3 Months	3 months after enrollment	Kemp Quality of Life score at 3 months compared to baseline. Score is 1-7 with higher scores indicating higher quality of life.
Other	Substance Use Treatment Utilization	12 months	percentage of participants self-reporting engagement in community substance use treatment programs
Other	Recruitment	12 months	Percentage of those approached who enroll in the study
Other	Continued Naltrexone Use After Intervention Period	3 months	Percentage of enrolled who self reported continuing treatment with naltrexone through their primary physician after the end of the study intervention period
Other	Change in ED Utilization	12 months before and after enrollment	Change in the number of emergency department visits determined by electronic medical record review
Other	Change in WHO Drinking Risk Level	3 months after enrollment	Change in World Health Organization drinking risk level from baseline. Risk levels are scored 1-4 with higher scores indicating more severe health risk from alcohol use

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants Retained in Study at 3 Months	3 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Retention at 12 Months	12 months	These data were not collected due to COVID-19 pandemic disruptions.
PRIMARY	Change in Daily Total Alcohol Consumption From Baseline at 3 Months	3 months after enrollment		drinks per day	MEDIAN
PRIMARY	Change in Total Alcohol Consumption at 12 Months	12 months after enrollment	These data were not collected due to COVID-19 pandemic disruptions.
SECONDARY	Change in Quality of Life Score at 3 Months	3 months after enrollment		score on a scale	MEAN
OTHER_PRE_SPECIFIED	Substance Use Treatment Utilization	12 months
OTHER_PRE_SPECIFIED	Recruitment	12 months
OTHER_PRE_SPECIFIED	Continued Naltrexone Use After Intervention Period	3 months		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Change in ED Utilization	12 months before and after enrollment
OTHER_PRE_SPECIFIED	Change in WHO Drinking Risk Level	3 months after enrollment		score on a scale	MEDIAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Participants Retained in Study at 3 Months	Multimodal Intervention	27		Participants
Change in Daily Total Alcohol Consumption From Baseline at 3 Months	Multimodal Intervention	-7.5	95% Confidence Interval -8.6 to -5.9	drinks per day
Change in Quality of Life Score at 3 Months	Multimodal Intervention	1.2	95% Confidence Interval 0.5 to 1.9	score on a scale
Continued Naltrexone Use After Intervention Period	Multimodal Intervention	22		Participants
Change in WHO Drinking Risk Level	Multimodal Intervention	-2	Inter-Quartile Range -3 to 0	score on a scale
Change in Alcohol Related Life Consequences (Short Inventory of Problems Scale, Version 2R: SIP-2R)	Multimodal Intervention	-13	Inter-Quartile Range -19 to -7	score on a scale
Receipt of All Study Naltrexone Injections	Multimodal Intervention	23		Participants

Source ClinicalTrials.gov

Participant flow5

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Multimodal Intervention	179
Overall Study	Screened for Eligibility	Multimodal Intervention	55
Overall Study	Enrolled and Received First Injection	Multimodal Intervention	32
Overall Study	COMPLETED	Multimodal Intervention	23
Overall Study	NOT COMPLETED	Multimodal Intervention	156

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	At risk
Total, all-cause mortality	Multimodal Intervention	32
Total, other adverse events	Multimodal Intervention	32
Total, serious adverse events	Multimodal Intervention	32

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36328851	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04094584

GET https://conductscience.org/api/trials/v1/NCT04094584/registered

API reference For AI assistants