Trial Outcomes & Findings for ED Initiated Oral Naltrexone for AUD (NCT NCT04817410)

NCT ID: NCT04817410

Last Updated: 2025-08-26

Results Overview

Number of participant enrolled with engagement in care of comprehensive addiction treatment

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2025-08-26

Participant Flow

This was a prospective single-arm, open-label, nonrandomized clinical trial in patients with moderate to severe AUD presenting to the Mount Sinai Beth Israel ED between September 2021 and October 2023.

Participant milestones

Measure	Oral Naloxone Oral Naltrexone initiation Emergency Department Initiated Oral Naltrexone: Emergency Department Initiated Oral Naltrexone
Overall Study STARTED	29
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Oral Naloxone Oral Naltrexone initiation Emergency Department Initiated Oral Naltrexone: Emergency Department Initiated Oral Naltrexone
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	3

Baseline Characteristics

ED Initiated Oral Naltrexone for AUD

Baseline characteristics by cohort

Measure	Oral Naltrexone n=21 Participants Oral Naltrexone
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Highest Level of Education Some high school, no diploma	4 Participants n=5 Participants
Highest Level of Education high school graduate/GED equivalent	3 Participants n=5 Participants
Highest Level of Education Technical/trade/vocational school	2 Participants n=5 Participants
Highest Level of Education Junior (2 year) college	1 Participants n=5 Participants
Highest Level of Education Some college (4 year college or university)	5 Participants n=5 Participants
Highest Level of Education College graduate (4 year college or university)	3 Participants n=5 Participants
Highest Level of Education Post-college/graduate degree	1 Participants n=5 Participants
Highest Level of Education Missing	2 Participants n=5 Participants
Estimated Total Income Less than $1,00	2 Participants n=5 Participants
Estimated Total Income $10,001-$20,00	1 Participants n=5 Participants
Estimated Total Income 20,001-$40,000	3 Participants n=5 Participants
Estimated Total Income $40,001 or more	8 Participants n=5 Participants
Estimated Total Income Don't know/missing	7 Participants n=5 Participants
Past-year Employment Status Unemployed	4 Participants n=5 Participants
Past-year Employment Status Employed	7 Participants n=5 Participants
Past-year Employment Status Disabled, permanently or temporarily	3 Participants n=5 Participants
Past-year Employment Status Other	7 Participants n=5 Participants
Health Insurance Coverage Covered by health plan	18 Participants n=5 Participants
Health Insurance Coverage Not Covered by health plan	3 Participants n=5 Participants
Concerned about stable housing over the next two months Yes	9 Participants n=5 Participants
Concerned about stable housing over the next two months No	12 Participants n=5 Participants
Incarcerated in the last 12 months Yes	0 Participants n=5 Participants
Incarcerated in the last 12 months No	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14

Number of participant enrolled with engagement in care of comprehensive addiction treatment

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 Engaged in treatment at 14-days	6 Participants
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 Not engaged in treatment at 14-days	15 Participants

PRIMARY outcome

Timeframe: Day 30

Number of participant enrolled with engagement in care of comprehensive addiction treatment

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 Engaged in treatment at 30-days	7 Participants
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 Not engaged in treatment at 30-days	14 Participants

SECONDARY outcome

Timeframe: 7-days prior to enrollment to day of enrollment (baseline)

Baseline

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Number of Alcoholic Drinks Per Day	4.29 # of drinks consumed per day Interval 2.29 to 7.57

SECONDARY outcome

Timeframe: 30-days

Population: 30-days

30-days

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Number of Daily Drinks	0.73 # of drinks consumed per day Interval 0.0 to 2.81

SECONDARY outcome

Timeframe: up to 30 days

Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Daily Alcohol Craving Scale	8.27 score on a scale Interval 4.65 to 11.75

SECONDARY outcome

Timeframe: Day 14

Population: 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.

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.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Guidelines Regimen Information Program (GRIP) Guide at Day 14	4.5 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Day 30

Population: 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.

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.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Guidelines Regimen Information Program (GRIP) Guide at Day 30	4 units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: Day 14

Population: Pill count at day 14. Note: Participants did not return to clinic so pill counts were not collected.

Adherence to daily oral naltrexone measured using pill counts.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 30

Population: Pill counts at day 30 Note: Participants did not return to clinic so pill counts were not collected.

Adherence to daily oral naltrexone measured using pill counts.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Number of Heavy Drinking Days	0.0 days Interval 0.0 to 0.17

SECONDARY outcome

Timeframe: up to 30-days

Population: Participants indicated the number of inpatient admissions, outpatient visits and emergency department visits over the preceding 7-days at baseline, 14-days and 30-days. Comparison of total reported admissions or visits were made using the Friedman test. No admissions or visits counted as a 0 for comparing across timepoints. If no response was provided at any of the three time points, the participant data was not used in the comparison.

Participants indicated the number of inpatient admissions, outpatient visits and emergency department visits over the preceding 7-days at baseline up to 30-days. Comparison of total reported admissions or visits were made using the Friedman test. No admissions or visits counted as a 0 for comparing across timepoints. If no response was provided at any of the three time points, the participant data was not used in the comparison.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Health Services Utilization Survey Inpatient Admissions - baseline	0 number of occurrences Interval 0.0 to 0.0
Health Services Utilization Survey outpatient visits -baseline	0 number of occurrences Interval 0.0 to 1.0
Health Services Utilization Survey ED visits - baseline	0 number of occurrences Interval 0.0 to 0.0
Health Services Utilization Survey Inpatient admissions-day 14 preceding 7-days at baseline)	0 number of occurrences Interval 0.0 to 0.0
Health Services Utilization Survey Outpatient visits-day 14	0.5 number of occurrences Interval 0.0 to 1.0
Health Services Utilization Survey Emergency Department Visits - day 14	0 number of occurrences Interval 0.0 to 0.0
Health Services Utilization Survey Inpatient admission - day 30	0 number of occurrences Interval 0.0 to 0.0
Health Services Utilization Survey Outpatient visits - day 30	0 number of occurrences Interval 0.0 to 1.0
Health Services Utilization Survey ED visits - day 30	0 number of occurrences Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Day 30

Population: Self-reported general health was collected on a 5-item scale ranging from: excellent, very good, good, fair, and poor. An unhealthy days score was obtained by summing the number of physically unhealthy and mentally unhealthy days. The minimum score is 0 and the maximum score is 30 unhealthy days.

Number of unhealthy days using the HRQoL. The HRQoL assesses core health days and activity limitations. Self-reported general health was collected on a 5-item scale ranging from: excellent, very good, good, fair, and poor. An unhealthy days score was obtained by summing the number of physically unhealthy and mentally unhealthy days. The minimum score is 0 and the maximum score is 30 unhealthy days, even if the number of unhealthy days totals more than 30. If no response was provided at the time points under comparison, the participant data was not used in the comparison.

Outcome measures

Measure	Oral Naltrexone n=18 Participants Received at least one dose of oral naltrexone
Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL)	11.5 unhealthy days Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: Day 30

Medication side effects of oral naltrexone measured using PRISE survey - is a patient self-report measure used to identify and evaluate the tolerability of side effect symptom. This scale is a 7-item assessment of the side effects in the following symptom areas; gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms and for each domain the patient rates whether these symptoms are tolerable or distressing. Higher score represents more side-effects. What is reported below are the number of participants reporting side effects for each symptom.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
The Patient Rated Inventory of Side Effects (PRISE) Survey Genital/Urinary	8 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Gastrointestinal	10 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Heart	6 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Skin	3 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Nervous System	6 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Sleep	10 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Sexual Functioning	6 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Other	11 participants
The Patient Rated Inventory of Side Effects (PRISE) Survey Eyes/Ears	4 participants

SECONDARY outcome

Timeframe: Baseline

Population: Three elements of satisfaction were assessed: 1) convenience of screening, 2) difficulty of screening and 3) satisfaction with screening. Each question could be scored on scale of 0-6. For convenience of screening, lower numbers indicated more convenience. For difficulty of screening, lower numbers represent less difficulty. For satisfaction, higher numbers represent greater satisfaction.

Three elements of satisfaction were assessed: 1) convenience of screening, 2) difficulty of screening and 3) satisfaction with screening. Each question could be scored on scale of 0-6. For convenience of screening, lower numbers indicated more convenience. For difficulty of screening, lower numbers represent less difficulty. For satisfaction, higher numbers represent greater satisfaction.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
AUD Program Satisfaction Survey at Baseline Satisfaction with screening · 0	1 Participants
AUD Program Satisfaction Survey at Baseline Satisfaction with screening · 1	1 Participants
AUD Program Satisfaction Survey at Baseline Satisfaction with screening · 2	1 Participants
AUD Program Satisfaction Survey at Baseline Satisfaction with screening · 3	0 Participants
AUD Program Satisfaction Survey at Baseline Satisfaction with screening · 4	1 Participants
AUD Program Satisfaction Survey at Baseline Satisfaction with screening · 5	1 Participants
AUD Program Satisfaction Survey at Baseline Satisfaction with screening · 6	16 Participants
AUD Program Satisfaction Survey at Baseline Convenience of screening · 0	14 Participants
AUD Program Satisfaction Survey at Baseline Convenience of screening · 1	1 Participants
AUD Program Satisfaction Survey at Baseline Convenience of screening · 2	1 Participants
AUD Program Satisfaction Survey at Baseline Convenience of screening · 3	2 Participants
AUD Program Satisfaction Survey at Baseline Convenience of screening · 4	0 Participants
AUD Program Satisfaction Survey at Baseline Convenience of screening · 5	1 Participants
AUD Program Satisfaction Survey at Baseline Convenience of screening · 6	2 Participants
AUD Program Satisfaction Survey at Baseline Difficulty of screening · 0	13 Participants
AUD Program Satisfaction Survey at Baseline Difficulty of screening · 1	3 Participants
AUD Program Satisfaction Survey at Baseline Difficulty of screening · 2	2 Participants
AUD Program Satisfaction Survey at Baseline Difficulty of screening · 3	0 Participants
AUD Program Satisfaction Survey at Baseline Difficulty of screening · 4	0 Participants
AUD Program Satisfaction Survey at Baseline Difficulty of screening · 5	1 Participants
AUD Program Satisfaction Survey at Baseline Difficulty of screening · 6	2 Participants

SECONDARY outcome

Timeframe: Day 30

Number of participants who transition from oral to long acting injectable naloxone.

Outcome measures

Measure	Oral Naltrexone n=21 Participants Received at least one dose of oral naltrexone
Number of Participants Who Transition to LA Injectable	0 Participants

Adverse Events

Oral Naltrexone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ethan Cowan

Rutgers New Jersey Medical School

Phone: 917-447-4964

Email: ethan.cowan@rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place