Alcohol Use Disorder
Conditions
Keywords
Medication Assisted Treatment, Emergency Department, Naltrexone
Brief summary
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.
Detailed description
Overview The study will be comprised of two components outlined below: 1. 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. 2. 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.
Interventions
DRUGEmergency Department Initiated Oral Naltrexone
Emergency Department Initiated Oral Naltrexone
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergency Department patients 18 years of age or older * Treated in the ED during screening hours * Moderate to severe AUD as determined by DSM-5 criteria * Able to speak and understand English * Medically stable for an interview as determined by their primary ED provider * Willing and able to consent to study participation * Two points of contact available for follow-up
Exclusion criteria
* ED patients younger than 18 years of age * Medically or psychiatrically unstable as determined by the ED provider * Unable to speak or understand English * Unable to provide consent for study participation * Past year opioid dependence * Urine drug screen positive for opioids * Current or anticipated need for opioid medications for pain * Anticipated surgical procedure within 14-day of ED visit * Serologic evidence of liver disease (LFTs 3X normal) within 7 days of enrollment * Cirrhosis either by PMH or self-report * Pregnant or breastfeeding * Lacking contact information for follow-up * Requiring in-patient admission for medical or psychiatric reasons * Patient receiving a sexual assault forensics exam (SAFE) * Patient suspected of having COVID-19 * Patient is actively suicidal or homicidal * Previously enrolled in either the implementation or feasibility phase of the study * Be a prisoner or in police custody at the time of the index ED visit * Be currently (anytime within the last 14 days) enrolled in formal addiction treatment, including by court order.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Alcoholic Drinks Per Day | 7-days prior to enrollment to day of enrollment (baseline) | Baseline |
| Number of Daily Drinks | 30-days | 30-days |
| 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. |
| 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. |
| 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. |
| Number of Pills in Bottle at Day 14 | Day 14 | Adherence to daily oral naltrexone measured using pill counts. |
| Number of Pills in Bottle at Day 30 | Day 30 | Adherence to daily oral naltrexone measured using pill counts. |
| 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. |
| Health Services Utilization Survey | up to 30-days | 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. |
| Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL) | Day 30 | 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. |
| The Patient Rated Inventory of Side Effects (PRISE) Survey | 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. |
| AUD Program Satisfaction Survey at Baseline | 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. |
| Number of Participants Who Transition to LA Injectable | Day 30 | Number of participants who transition from oral to long acting injectable naloxone. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Oral Naltrexone Oral Naltrexone | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Oral Naltrexone |
|---|---|
| Age, Continuous | 41 years |
| Concerned about stable housing over the next two months No | 12 Participants |
| Concerned about stable housing over the next two months Yes | 9 Participants |
| Estimated Total Income $10,001-$20,00 | 1 Participants |
| Estimated Total Income 20,001-$40,000 | 3 Participants |
| Estimated Total Income $40,001 or more | 8 Participants |
| Estimated Total Income Don't know/missing | 7 Participants |
| Estimated Total Income Less than $1,00 | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Health Insurance Coverage Covered by health plan | 18 Participants |
| Health Insurance Coverage Not Covered by health plan | 3 Participants |
| Highest Level of Education College graduate (4 year college or university) | 3 Participants |
| Highest Level of Education high school graduate/GED equivalent | 3 Participants |
| Highest Level of Education Junior (2 year) college | 1 Participants |
| Highest Level of Education Missing | 2 Participants |
| Highest Level of Education Post-college/graduate degree | 1 Participants |
| Highest Level of Education Some college (4 year college or university) | 5 Participants |
| Highest Level of Education Some high school, no diploma | 4 Participants |
| Highest Level of Education Technical/trade/vocational school | 2 Participants |
| Incarcerated in the last 12 months No | 21 Participants |
| Incarcerated in the last 12 months Yes | 0 Participants |
| Past-year Employment Status Disabled, permanently or temporarily | 3 Participants |
| Past-year Employment Status Employed | 7 Participants |
| Past-year Employment Status Other | 7 Participants |
| Past-year Employment Status Unemployed | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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
Time frame: Day 14
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Naltrexone | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Engaged in treatment at 14-days | 6 Participants |
| Oral Naltrexone | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 | Not engaged in treatment at 14-days | 15 Participants |
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
Time frame: Day 30
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Naltrexone | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Engaged in treatment at 30-days | 7 Participants |
| Oral Naltrexone | Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30 | Not engaged in treatment at 30-days | 14 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Convenience of screening | 5 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Convenience of screening | 6 | 2 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Satisfaction with screening | 0 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Satisfaction with screening | 1 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Satisfaction with screening | 2 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Satisfaction with screening | 3 | 0 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Satisfaction with screening | 4 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Satisfaction with screening | 5 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Satisfaction with screening | 6 | 16 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Convenience of screening | 0 | 14 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Convenience of screening | 1 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Convenience of screening | 2 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Convenience of screening | 3 | 2 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Convenience of screening | 4 | 0 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Difficulty of screening | 0 | 13 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Difficulty of screening | 1 | 3 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Difficulty of screening | 2 | 2 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Difficulty of screening | 3 | 0 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Difficulty of screening | 4 | 0 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Difficulty of screening | 5 | 1 Participants |
| Oral Naltrexone | AUD Program Satisfaction Survey at Baseline | Difficulty of screening | 6 | 2 Participants |
Secondary
Daily Alcohol Craving Scale
Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity.
Time frame: up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Naltrexone | Daily Alcohol Craving Scale | 8.27 score on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Naltrexone | Guidelines Regimen Information Program (GRIP) Guide at Day 14 | 4.5 units on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Naltrexone | Guidelines Regimen Information Program (GRIP) Guide at Day 30 | 4 units on a scale |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oral Naltrexone | Health Services Utilization Survey | Outpatient visits - day 30 | 0 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | ED visits - day 30 | 0 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | Inpatient Admissions - baseline | 0 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | outpatient visits -baseline | 0 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | ED visits - baseline | 0 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | Inpatient admissions-day 14 preceding 7-days at baseline) | 0 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | Outpatient visits-day 14 | 0.5 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | Emergency Department Visits - day 14 | 0 number of occurrences |
| Oral Naltrexone | Health Services Utilization Survey | Inpatient admission - day 30 | 0 number of occurrences |
Secondary
Number of Alcoholic Drinks Per Day
Baseline
Time frame: 7-days prior to enrollment to day of enrollment (baseline)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Naltrexone | Number of Alcoholic Drinks Per Day | 4.29 # of drinks consumed per day |
Secondary
Number of Daily Drinks
30-days
Time frame: 30-days
Population: 30-days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Naltrexone | Number of Daily Drinks | 0.73 # of drinks consumed per day |
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.
Time frame: up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Naltrexone | Number of Heavy Drinking Days | 0.0 days |
Secondary
Number of Participants Who Transition to LA Injectable
Number of participants who transition from oral to long acting injectable naloxone.
Time frame: Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Naltrexone | Number of Participants Who Transition to LA Injectable | 0 Participants |
Secondary
Number of Pills in Bottle at Day 14
Adherence to daily oral naltrexone measured using pill counts.
Time frame: Day 14
Population: 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
Adherence to daily oral naltrexone measured using pill counts.
Time frame: Day 30
Population: Pill counts at day 30 Note: Participants did not return to clinic so pill counts were not collected.
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Naltrexone | Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL) | 11.5 unhealthy days |
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.
Time frame: Day 30
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Gastrointestinal | 10 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Heart | 6 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Other | 11 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Skin | 3 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Nervous System | 6 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Genital/Urinary | 8 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Sleep | 10 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Sexual Functioning | 6 participants |
| Oral Naltrexone | The Patient Rated Inventory of Side Effects (PRISE) Survey | Eyes/Ears | 4 participants |