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This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.
Overview
The study will be comprised of two components outlined below:
Site Implementation Component
In this component implementation science strategies will be used to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability and linkage pathways. Three specific aims are to, 1) optimize registered nurse (RN) driven non-targeted alcohol use screening supplemented with secondary screening using DSM-5 criteria for AUD and an SBIRT (screening, brief intervention and referral to treatment) intervention administered by trained staff. 2) During a 3-month period, use continuous quality improvement methods to decrease the time for completion of AUD screening to an interval that is acceptable to ED patients and ED providers and 3) Assess willingness to initiate oral naltrexone among ED patients with moderate to severe AUD. Ten (10) patients will be enrolled in phase 1.
Oral Naltrexone Feasibility Component
In this component the study team aims to assess the feasibility of initiating treatment in ED patients with moderate to severe AUD on oral naltrexone, an evidence based and accepted standard of care treatment for AUD. Specifically, 1) over an 8-month period the study team aims to identify 20 patients with moderate to severe AUD eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be receive a standard SBIRT intervention and be provided with immediate oral naltrexone initiation in the ED with a 14-day starter pack at the time of ED discharge. All participants will receive facilitated linkage to comprehensive out-patient care. 2) The study team aims will evaluate the impact of immediate ED initiated oral naltrexone with the primary outcome being engagement in comprehensive addiction care at 14 and 30 days post enrollment. Secondary outcomes include medication adherence, changes in daily alcohol consumption, number of heavy drinking days, hospital admissions and ED utilization, transition to long-acting injectable naltrexone and alcohol craving. 3) Lastly, the study team will collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive randomized controlled trial of ED-initiated oral naltrexone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Naloxone | Experimental | Oral Naltrexone initiation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Department Initiated Oral Naltrexone | Drug | Emergency Department Initiated Oral Naltrexone |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Number of participant enrolled with engagement in care of comprehensive addiction treatment | Day 14 |
| Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Number of participant enrolled with engagement in care of comprehensive addiction treatment | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Alcoholic Drinks Per Day | Baseline | 7-days prior to enrollment to day of enrollment (baseline) |
| Number of Daily Drinks | 30-days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethan Cowan, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Beth Israel | New York | New York | 10003 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Naloxone | Oral Naltrexone initiation Emergency Department Initiated Oral Naltrexone: Emergency Department Initiated Oral Naltrexone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Naltrexone | Oral Naltrexone |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Number of participant enrolled with engagement in care of comprehensive addiction treatment | Posted | Count of Participants | Participants | Day 14 |
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30-days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Naltrexone | Received at least 1 dose of oral naltrexone | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ethan Cowan | Rutgers New Jersey Medical School | 917-447-4964 | ethan.cowan@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2021 | May 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 26, 2021 | May 5, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 30-days |
| Daily Alcohol Craving Scale | Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity. | up to 30 days |
| Guidelines Regimen Information Program (GRIP) Guide at 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. | Day 14 |
| Guidelines Regimen Information Program (GRIP) Guide at 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. | Day 30 |
| Number of Pills in Bottle at Day 14 | Adherence to daily oral naltrexone measured using pill counts. | Day 14 |
| Number of Pills in Bottle at Day 30 | Adherence to daily oral naltrexone measured using pill counts. | Day 30 |
| Number of Heavy Drinking 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. | up to 30 days |
| Health Services Utilization Survey | 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. | up to 30-days |
| Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL) | 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. | Day 30 |
| The Patient Rated Inventory of Side Effects (PRISE) Survey | 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. | Day 30 |
| AUD Program Satisfaction Survey at Baseline | 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. | Baseline |
| Number of Participants Who Transition to LA Injectable | Number of participants who transition from oral to long acting injectable naloxone. | Day 30 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Highest Level of Education | Count of Participants | Participants |
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| Estimated Total Income | Count of Participants | Participants |
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| Past-year Employment Status | Count of Participants | Participants |
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| Health Insurance Coverage | Count of Participants | Participants |
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| Concerned about stable housing over the next two months | Count of Participants | Participants |
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| Incarcerated in the last 12 months | Count of Participants | Participants |
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| Primary | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Number of participant enrolled with engagement in care of comprehensive addiction treatment | Posted | Count of Participants | Participants | Day 30 |
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| Secondary | Number of Alcoholic Drinks Per Day | Baseline | Posted | Median | Inter-Quartile Range | # of drinks consumed per day | 7-days prior to enrollment to day of enrollment (baseline) |
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| Secondary | Number of Daily Drinks | 30-days | 30-days | Posted | Median | Inter-Quartile Range | # of drinks consumed per day | 30-days |
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| Secondary | Daily Alcohol Craving Scale | Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity. | Posted | Median | Inter-Quartile Range | score on a scale | up to 30 days |
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| Secondary | Guidelines Regimen Information Program (GRIP) Guide at 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Day 14 |
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| Secondary | Guidelines Regimen Information Program (GRIP) Guide at 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Day 30 |
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| Secondary | Number of Pills in Bottle at Day 14 | Adherence to daily oral naltrexone measured using pill counts. | Pill count at day 14. Note: Participants did not return to clinic so pill counts were not collected. | Posted | Day 14 |
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| Secondary | Number of Pills in Bottle at Day 30 | Adherence to daily oral naltrexone measured using pill counts. | Pill counts at day 30 Note: Participants did not return to clinic so pill counts were not collected. | Posted | Day 30 |
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| Secondary | Number of Heavy Drinking 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. | Posted | Median | Inter-Quartile Range | days | up to 30 days |
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| Secondary | Health Services Utilization Survey | 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. | 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. | Posted | Median | Inter-Quartile Range | number of occurrences | up to 30-days |
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| Secondary | Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL) | 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. | 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. | Posted | Median | Inter-Quartile Range | unhealthy days | Day 30 |
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| Secondary | The Patient Rated Inventory of Side Effects (PRISE) Survey | 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. | Posted | Number | participants | Day 30 |
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| Secondary | AUD Program Satisfaction Survey at Baseline | 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. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Number of Participants Who Transition to LA Injectable | Number of participants who transition from oral to long acting injectable naloxone. | Posted | Count of Participants | Participants | Day 30 |
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| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Inpatient admissions-day 14 preceding 7-days at baseline) |
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| Outpatient visits-day 14 |
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| Emergency Department Visits - day 14 |
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| Inpatient admission - day 30 |
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| Outpatient visits - day 30 |
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| ED visits - day 30 |
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| Title | Measurements |
|---|
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| Nervous System |
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| Genital/Urinary |
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| Sleep |
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| Sexual Functioning |
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| Other |
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| Eyes/Ears |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| Convenience of screening |
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| Difficulty of screening |
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