Alcohol Use Disorder Clinical Trial
Official title:
Novel Interventions for Alcohol Dependent Frequent Emergency Department Users: Phase IV, Randomized, Open-label, Non-placebo-controlled Study of Extended-release Naltrexone and Care Management on Healthcare Use, Drinking, & Quality of Life
Verified date | April 2022 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | February 8, 2019 |
Est. primary completion date | February 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria Subjects must meet all of the following criteria to be eligible for study enrollment: 1. 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). 2. Emergency Department patient 3. Aged 18-80 4. 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. 5. Meet Diagnostic and Statistical Manual version IV (DSM-IV) criteria for alcohol dependence or & DSM-V criteria for alcohol use disorder, severe. 6. Have =2 days/week of heavy drinking (>4 drinks/day) 7. Capable of giving informed consent. Exclusion Criteria Subjects who meet any of the following criteria will be ineligible for study enrollment: 1. Active opioid dependence 2. Acute or chronic pain requiring opioid treatment 3. Acute liver injury (liver aminotransferase concentrations >5 times the upper limit of normal) 4. Health condition considered unsafe for inclusion (at discretion of PI and/or attending physician) 5. Lack of capacity or willingness to consent 6. Currently prescribed pharmacotherapy for alcohol dependence (not including treatment of acute alcohol withdrawal syndrome) 7. Previous significant adverse reaction to naltrexone or diluent 8. Pregnant, nursing, or not using effective methods of birth control 9. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Bellevue Hospital Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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:S221-4. doi: 10.2105/AJPH.2013.301373. Epub 2013 Oct 22. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Heavy Drinking Days | Self-reported | Month 3 | |
Secondary | Number of Heavy Drinking Days | Self-reported | Month 6 | |
Secondary | Number of Heavy Drinking Days | Self-reported | 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. | 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. | 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. | Month 12 | |
Secondary | Carbohydrate-deficient Transferrin (CDT) Levels | Month 3 | ||
Secondary | Carbohydrate-deficient Transferrin (CDT) Levels | Month 6 | ||
Secondary | Carbohydrate-deficient Transferrin (CDT) Levels | Month 12 | ||
Secondary | Gamma-glutamyl Transferase (GGT) Levels | Month 3 | ||
Secondary | Gamma-glutamyl Transferase (GGT) Levels | Month 6 | ||
Secondary | Gamma-glutamyl Transferase (GGT) Levels | 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). | 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). | 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). | Month 12 |
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