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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AA022989-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and continuing care in cooperation with clinic providers as well as how best to assess outcomes. Secondarily, the investigators will explore its effect on various health outcomes (healthcare utilization and engagement, expenditures, drinking and consequences, quality of life) as well as the association of patient-level characteristics (e.g. sex, race, baseline drinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is essential before planning a large-scale effectiveness trial (phase 2).
Aim #1: To conduct a feasibility and acceptability study of XR-NTX+CM treatment in alcohol dependent patients with frequent ED use.
Hypothesis: Enrollment of a limited number of subjects will allow identification of optimal processes for a definitive trial.
Aim #2: To conduct an analysis of the effect of this intervention on healthcare utilization and engagement, drinking outcomes, quality of life, and consequences of drinking (initial analysis will be exploratory).
Hypothesis: Measuring changes in healthcare utilization, drinking metrics, and indicators of quality of life and consequences will provide preliminary data on intervention effect size on various outcomes of interest to inform the second phase, definitive trial.
Aim #3: To identify patient-level characteristics associated with effectiveness.
Hypothesis: Exploratory analysis of patient and system-level characteristics possibly associated with effectiveness will inform treatment choice to maximize the probability of successful outcome. Factors assessed will include data collected in ongoing investigations of pharmacotherapy for alcohol dependence, including mu opioid receptor (OPRM1) genotypes, to facilitate comparison across study populations and settings.
This a phase IV, randomized, open-label, non-placebo-controlled, single-center study of the feasibility, acceptability, and effect of initiating treatment in the ED with extended-release naltrexone 380mg intramuscular injection compared to standard care in subjects with severe alcohol use disorders (i.e. alcohol dependence) and frequent emergency department use. In the first two years, we will finalize study preparations, recruit and randomize 50 subjects for the pilot phase of this study. The duration of each subject's participation will be 12 months. Thereafter, in the second phase of study, we will enroll an additional 250 subjects (for a total of 300 subjects) to address remaining feasibility and acceptability concerns and test effects.
The study investigators (PI and RA) will collect process data, including barriers and facilitators encountered in the completion of all study procedures. For the following study procedures, study investigators (the PI and RAs) will enter data directly into New York University Langone Medical Center (NYULMC) internal REDCap system for use on portable tablet computers.
Synopsis of Study Procedures:
The following study procedures are described in greater detail elsewhere in this protocol.
Patients will be prescreened for potential eligibility and added to an automated alert system linked to ED registration by Bellevue Care Managers as part of an ongoing quality improvement initiative. When a potentially eligible patient presents to the ED, an automated page will be delivered to the study PI and Bellevue ED social work and care management staff, prompting consultation and potential referral of the patient to study investigators (PI/RA) for recruitment (See 4.3 Subject Recruitment and Screening). ED medical providers (inclusive of ED physicians, nurses, social workers, and care managers) will notify study investigators (PI/RA) when potentially eligible patients are present in the ED. The medical provider will introduce the PI/RA to clinically sober and medically stable patients who have given their permission to be approached. The PI/RA will describe the study, confirm capacity to consent using the University of California San Diego Brief Assessment of Capacity to Consent to Research (UBACC), and obtain written informed consent. The PI/RA will confirm eligibility by performing a chart and laboratory review (liver enzymes, pregnancy, urine drug screen), history and examination, and diagnostic interview to confirm alcohol dependence and assess for opioid use and chronic pain. The PI/RA will conduct research intake assessments and interview and collect blood for biomarker (5mL) and genetic (10mL) analyses. The PI/RA will randomize subjects to intervention (XR-NTX+CM) or Standard Care using a random number generator with randomly permuted blocks with allocations contained within opaque sealed envelopes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm: XR-NTX+CM | Active Comparator | XR-NTX+CM (Extended Release Naltrexone + Care Management) |
|
| Standard Care Arm | No Intervention | Standard Care/Alcohol-Medical Management (MM) Only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XR-NTX+CM (Extended-Release Naltrexone plus Care Management) | Drug | The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Heavy Drinking Days | Self-reported | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Heavy Drinking Days | Self-reported | Month 6 |
| Number of Heavy Drinking Days | Self-reported | Month 12 |
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Inclusion Criteria
Subjects must meet all of the following criteria to be eligible for study enrollment:
English or Spanish speaking*
*Non-English Spanish speaking patients will not be enrolled initially until study documents have been translated, back translated, and approved by the Institutional Review Board (IRB).
Emergency Department patient
Aged 18-80
Have had >4 emergency department visits within 12 months for 2 consecutive 12-month periods. Period of time can be extended by up to 6 months if incarcerated or institutionalized for ≥ 6 months.
Meet Diagnostic and Statistical Manual version IV (DSM-IV) criteria for alcohol dependence or & DSM-V criteria for alcohol use disorder, severe.
Have ≥2 days/week of heavy drinking (>4 drinks/day)
Capable of giving informed consent.
Exclusion Criteria
Subjects who meet any of the following criteria will be ineligible for study enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan P McCormack, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23602314 | Background | McCormack RP, Williams AR, Goldfrank LR, Caplan AL, Ross S, Rotrosen J. Commitment to assessment and treatment: comprehensive care for patients gravely disabled by alcohol use disorders. Lancet. 2013 Sep 14;382(9896):995-7. doi: 10.1016/S0140-6736(12)62206-5. Epub 2013 Apr 19. No abstract available. | |
| 24148034 | Background | McCormack RP, Hoffman LF, Wall SP, Goldfrank LR. Resource-limited, collaborative pilot intervention for chronically homeless, alcohol-dependent frequent emergency department users. Am J Public Health. 2013 Dec;103 Suppl 2(Suppl 2):S221-4. doi: 10.2105/AJPH.2013.301373. Epub 2013 Oct 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm: XR-NTX+CM | XR-NTX+CM (Extended Release Naltrexone + Care Management) XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral. |
| FG001 | Standard Care Arm | Standard Care/Alcohol-Medical Management (MM) Only |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm: XR-NTX+CM | XR-NTX+CM (Extended Release Naltrexone + Care Management) XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Heavy Drinking Days | Self-reported | Posted | Mean | Standard Deviation | days | Month 3 |
|
52 weeks
During research visits in the Emergency Department (ED), the PI/RA will collect adverse event information.
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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 | Intervention Arm: XR-NTX+CM | XR-NTX+CM (Extended Release Naltrexone + Care Management) XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan P. McCormack, MD | NYU Langone Health | 212-562-6561 | Ryan.McCormack@nyulangone.org |
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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 | Oct 9, 2018 | Apr 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D004630 | Emergencies |
| D010342 | Patient Acceptance of Health Care |
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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|
|
| Short Inventory of Problems Related to Alcohol (SIP-2R) Score | SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. | Month 3 |
| Short Inventory of Problems Related to Alcohol (SIP-2R) Score | SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. | Month 6 |
| Short Inventory of Problems Related to Alcohol (SIP-2R) Score | SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. | Month 12 |
| Carbohydrate-deficient Transferrin (CDT) Levels | Month 3 |
| Carbohydrate-deficient Transferrin (CDT) Levels | Month 6 |
| Carbohydrate-deficient Transferrin (CDT) Levels | Month 12 |
| Gamma-glutamyl Transferase (GGT) Levels | Month 3 |
| Gamma-glutamyl Transferase (GGT) Levels | Month 6 |
| Gamma-glutamyl Transferase (GGT) Levels | Month 12 |
| EuroQoL-5 Dimensions (EQ-5D) Score | EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state). | Month 3 |
| EuroQoL-5 Dimensions (EQ-5D) Score | EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state). | Month 6 |
| EuroQoL-5 Dimensions (EQ-5D) Score | EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state). | Month 12 |
| 24976534 | Background | McCormack RP, Hoffman LF, Norman M, Goldfrank LR, Norman EM. Voices of homeless alcoholics who frequent Bellevue Hospital: a qualitative study. Ann Emerg Med. 2015 Feb;65(2):178-86.e6. doi: 10.1016/j.annemergmed.2014.05.025. Epub 2014 Jun 26. |
| 25447556 | Background | McCormack RP, Gallagher T, Goldfrank LR, Caplan AL. Including frequent emergency department users with severe alcohol use disorders in research: assessing capacity. Ann Emerg Med. 2015 Feb;65(2):172-7.e1. doi: 10.1016/j.annemergmed.2014.09.027. Epub 2014 Oct 23. |
| 24412058 | Background | Hamilton BH, Sheth A, McCormack RT, McCormack RP. Imaging of frequent emergency department users with alcohol use disorders. J Emerg Med. 2014 Apr;46(4):582-7. doi: 10.1016/j.jemermed.2013.08.129. Epub 2014 Jan 10. |
| 20363090 | Background | Lee JD, Grossman E, DiRocco D, Truncali A, Hanley K, Stevens D, Rotrosen J, Gourevitch MN. Extended-release naltrexone for treatment of alcohol dependence in primary care. J Subst Abuse Treat. 2010 Jul;39(1):14-21. doi: 10.1016/j.jsat.2010.03.005. Epub 2010 Apr 2. |
| 24846619 | Background | Collins SE, Saxon AJ, Duncan MH, Smart BF, Merrill JO, Malone DK, Jackson TR, Clifasefi SL, Joesch J, Ries RK. Harm reduction with pharmacotherapy for homeless people with alcohol dependence: protocol for a randomized controlled trial. Contemp Clin Trials. 2014 Jul;38(2):221-34. doi: 10.1016/j.cct.2014.05.008. Epub 2014 May 17. |
| BG001 | Standard Care Arm | Standard Care/Alcohol-Medical Management (MM) Only |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard Care/Alcohol-Medical Management (MM) Only |
|
|
| Secondary | Number of Heavy Drinking Days | Self-reported | Posted | Mean | Standard Deviation | days | Month 6 |
|
|
|
| Secondary | Number of Heavy Drinking Days | Self-reported | Posted | Mean | Standard Deviation | days | Month 12 |
|
|
|
| Secondary | Short Inventory of Problems Related to Alcohol (SIP-2R) Score | SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| Secondary | Short Inventory of Problems Related to Alcohol (SIP-2R) Score | SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
|
|
| Secondary | Short Inventory of Problems Related to Alcohol (SIP-2R) Score | SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
|
|
|
| Secondary | Carbohydrate-deficient Transferrin (CDT) Levels | Posted | Mean | Standard Deviation | %CDT | Month 3 |
|
|
|
| Secondary | Carbohydrate-deficient Transferrin (CDT) Levels | Posted | Mean | Standard Deviation | %CDT | Month 6 |
|
|
|
| Secondary | Carbohydrate-deficient Transferrin (CDT) Levels | Posted | Mean | Standard Deviation | %CDT | Month 12 |
|
|
|
| Secondary | Gamma-glutamyl Transferase (GGT) Levels | Posted | Mean | Standard Deviation | units/liter | Month 3 |
|
|
|
| Secondary | Gamma-glutamyl Transferase (GGT) Levels | Posted | Mean | Standard Deviation | units/liter | Month 6 |
|
|
|
| Secondary | Gamma-glutamyl Transferase (GGT) Levels | Posted | Mean | Standard Deviation | units/liter | Month 12 |
|
|
|
| Secondary | EuroQoL-5 Dimensions (EQ-5D) Score | EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state). | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| Secondary | EuroQoL-5 Dimensions (EQ-5D) Score | EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state). | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
|
|
| Secondary | EuroQoL-5 Dimensions (EQ-5D) Score | EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state). | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Standard Care Arm | Standard Care/Alcohol-Medical Management (MM) Only | 0 | 25 | 0 | 25 | 0 | 25 |
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| D015438 | Health Behavior |
| D001519 | Behavior |