Alcohol Use Disorder — In Hospital IM Naltrexone: A Pilot Study
Citation(s)
(CIVHC) CfIViH CO APCD Overview. https://www.civhc.org/get-data/co-apcd-info/. Published 2021. Accessed September 14, 2021.
Abuse S Mental Health Services Administration.(2017). Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044, NSDUH Series H-52). Rockville, MD: C
Administration SAaMHS Incorporating Alcohol Pharmacotherapies into Medical Practice: Treatment Improvement Protcol (TIP) Series, No. 49. Rockville, MD2009.
Alkermes Alkermes Hospital Inpatient Free Trail Program. Alkermes. https://www.alkermeshospitalprogram.com/. Published 2021. Accessed September 16, 2021.
Anton RF, Moak DH, Waid LR, Latham PK, Malcolm RJ, Dias JK Naltrexone and cognitive behavioral therapy for the treatment of outpatient alcoholics: results of a placebo-controlled trial. Am J Psychiatry. 1999 Nov;156(11):1758-64. doi: 10.1176/ajp.156.11.1
Cacciola JS, Alterman AI, McLellan AT, Lin YT, Lynch KG Initial evidence for the reliability and validity of a "Lite" version of the Addiction Severity Index. Drug Alcohol Depend. 2007 Mar 16;87(2-3):297-302. doi: 10.1016/j.drugalcdep.2006.09.002. Epub 2
Calcaterra SL, McBeth L, Keniston AM, Burden M The Development and Implementation of a Hospitalist-Directed Addiction Medicine Consultation Service to Address a Treatment Gap. J Gen Intern Med. 2022 Apr;37(5):1065-1072. doi: 10.1007/s11606-021-06849-8. E
Charlson ME, Pompei P, Ales KL, MacKenzie CR A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Chen C, Yoon Y Trends in Alcohol-Related Morbidity Among Community Hospital Discharges, United States, 2000-2015. Surveillance Report# 112. Arlington, VA. 2018.
Compass HD Health Data Compass. https://pub.healthdatacompass.org/data-delivery-services/health-data-compass-resources. Published 2019. Accessed September 14, 2021
Croop RS, Faulkner EB, Labriola DF The safety profile of naltrexone in the treatment of alcoholism. Results from a multicenter usage study. The Naltrexone Usage Study Group. Arch Gen Psychiatry. 1997 Dec;54(12):1130-5. doi: 10.1001/archpsyc.1997.01830240
Financing CDoHCPa Colorado Hospital Transformation Program. Colorado Office State Web Portal. https://hcpf.colorado.gov/colorado-hospital-transformation-program. Published 2021. Accessed September 16, 2021
Lee EC, Whitehead AL, Jacques RM, Julious SA The statistical interpretation of pilot trials: should significance thresholds be reconsidered? BMC Med Res Methodol. 2014 Mar 20;14:41. doi: 10.1186/1471-2288-14-41.
McLellan A, Cacciola J, Zanis D The addiction severity index-lite. Center for the Studies on Addiction, University of Pennsylvania/Philadelphia VA Medical Center. 1997.
Murphy CE 4th, Wang RC, Montoy JC, Whittaker E, Raven M Effect of extended-release naltrexone on alcohol consumption: a systematic review and meta-analysis. Addiction. 2022 Feb;117(2):271-281. doi: 10.1111/add.15572. Epub 2021 Jun 28.
Roerecke M, Rehm J Alcohol use disorders and mortality: a systematic review and meta-analysis. Addiction. 2013 Sep;108(9):1562-78. doi: 10.1111/add.12231. Epub 2013 May 29.
Wei J, Defries T, Lozada M, Young N, Huen W, Tulsky J An inpatient treatment and discharge planning protocol for alcohol dependence: efficacy in reducing 30-day readmissions and emergency department visits. J Gen Intern Med. 2015 Mar;30(3):365-70. doi: 1
Weiner BJ, Lewis, C C., Stanick, C., Powell, B. J., Dorsey, C. N., Clary, A. S., Boynton, M. H., & Halko, H. Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure. Frank Porter Grah
In Hospital Administration of Extended-Release Naltrexone for Alcohol Use Disorder: A Pilot Study of Feasibility and Acceptability
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
