Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users

NCT02445339 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 13-009281K23AA022989-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alcohol Dependence; Alcohol Use Disorder

Keywords

Alcohol Dependence; Alcohol Use Disorder; Care Management; Case Management; Emergency Care Services; Emergency Department; Emergency Room; Extended-release naltrexone; Frequent Users; Health Care Utilization; Medical Management; Naltrexone; Population Health; Public Health; Vivitrol; XR-NTX; XR-NTX+CM; Alcoholism; Alcohol-Related Disorders; Central Nervous System Agents; Chemically-Induced Disorders; Clinical Trial; Emergency Medicine; Mental Disorders; Narcotic Antagonists; Peripheral Nervous System Agents; Pharmacologic Actions; Physiological Effects of Drugs; Sensory System Agents; Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Number of Heavy Drinking Days

  Self-reported

  Month 3

Secondary Outcomes (14)

• Number of Heavy Drinking Days

  Month 6

• Number of Heavy Drinking Days

  Month 12

• Short Inventory of Problems Related to Alcohol (SIP-2R) Score

  Month 3

• Short Inventory of Problems Related to Alcohol (SIP-2R) Score

  Month 6

• Short Inventory of Problems Related to Alcohol (SIP-2R) Score

  Month 12

Study Arms (2)

Intervention Arm: XR-NTX+CM

ACTIVE COMPARATOR

XR-NTX+CM (Extended Release Naltrexone + Care Management)

Drug: XR-NTX+CM (Extended-Release Naltrexone plus Care Management)

Standard Care Arm

NO INTERVENTION

Standard Care/Alcohol-Medical Management (MM) Only

Interventions

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.

Also known as: Vivitrol

Intervention Arm: XR-NTX+CM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who meet any of the following criteria will be ineligible for study enrollment:
• Active opioid dependence
• Acute or chronic pain requiring opioid treatment
• Acute liver injury (liver aminotransferase concentrations \>5 times the upper limit of normal)
• Lack of capacity or willingness to consent
• Currently prescribed pharmacotherapy for alcohol dependence (not including treatment of acute alcohol withdrawal syndrome)
• Previous significant adverse reaction to naltrexone or diluent
• Pregnant, nursing, or not using effective methods of birth control
• Prisoners (as defined by Office of Human Research Protection) at the time of enrollment ARE NOT ELIGIBLE for study entry. However, subjects who become prisoners after being enrolled will be included and not be withdrawn from the study. Patients on parole or probation are eligible for enrollment.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

Related Publications (7)

• 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.

  PMID: 23602314 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.

  PMID: 24148034 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.

  PMID: 24976534 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.

  PMID: 25447556 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.

  PMID: 24412058 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.

  PMID: 20363090 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.

  PMID: 24846619 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Emergencies; Patient Acceptance of Health Care; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Substance-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Ryan P. McCormack, MD
• Organization: NYU Langone Health

Ryan.McCormack@nyulangone.org

212-562-6561

Study Officials

• Ryan P McCormack, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: May 15, 2015
• Study Start: July 1, 2015
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: May 11, 2022
• Results First Posted: May 11, 2022

Record last verified: 2022-04

Locations

US (1)