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1.
Subst Abus ; 42(2): 140-147, 2021.
Article in English | MEDLINE | ID: covidwho-1180374

ABSTRACT

Background: The COVID-19 crisis presents new challenges and opportunities in managing alcohol use disorders, particularly for people unable to shelter in place due to homelessness or other reasons. Requiring abstinence for shelter engagement is impractical for many with severe alcohol use disorders and poses a modifiable barrier to self-isolation orders. Managed alcohol programs (MAPs) have successfully increased housing adherence for those with physical alcohol dependence in Canada, but to our knowledge, they have not been implemented in the United States. To avoid life-threatening alcohol withdrawal syndromes and to support adherence to COVID-19 self-isolation and quarantine orders, MAPs were piloted by the public health departments of San Francisco and Alameda counties. Development of MAPs: We describe implementation of a first-in-the-nation alcohol use disorder intervention of a MAP that emerged at three public health isolation settings within San Francisco and Alameda counties in California. All three interventions utilized a similar process to develop the protocol and implement the MAP that included identification of champions for system-level advocacy and engagement of stakeholders. Implementation of MAPs: We describe the creation and implementation of the distinct protocols. We provide examples of iterative changes to workflow processes and key lessons learned pertaining to protocol development, acceptability by stakeholders, alcohol procurement, documentation, and assessment. We discuss safety considerations, noting that there were no deaths or serious adverse events in any of the patients of the MAP during the 2-month implementation period. Conclusions: MAP pilots have been implemented in the US to aid adherence to isolation and quarantine setting guidelines. Lessons learned provide a foundation for their expansion as a recognized public health intervention for individuals with severe alcohol use disorders who are unable to stabilize within existing care systems. Based on the success of MAP implementation, efforts are under way to investigate alcohol management in homeless populations more broadly.


Subject(s)
Alcoholism/therapy , COVID-19/prevention & control , Harm Reduction , Housing , Ill-Housed Persons , Quarantine/methods , Substance Withdrawal Syndrome/prevention & control , Alcohol Abstinence , California , Central Nervous System Depressants/adverse effects , Central Nervous System Depressants/therapeutic use , Communicable Disease Control , Ethanol/adverse effects , Ethanol/therapeutic use , Humans , Implementation Science , Pilot Projects , Public Health , SARS-CoV-2 , San Francisco , Stakeholder Participation , Workflow
2.
Trials ; 21(1): 882, 2020 Oct 26.
Article in English | MEDLINE | ID: covidwho-892369

ABSTRACT

OBJECTIVES: We will evaluate the efficacy and safety of Melatonin, compared to the standard therapeutic regimen on clinical symptoms and serum inflammatory parameters in patients with confirmed COVID-19, who are moderately ill. TRIAL DESIGN: This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. PARTICIPANTS: All patients admitted to Severe Acute Respiratory Syndrome Departments of Shahid Mohammadi Hospital, Bandar Abbas, Iran will be screened for the following criteria. INCLUSION CRITERIA: 1. Age ≥20 years 2. Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction). 3. Moderate COVID-19 pneumonia (via computed tomography and or X-ray imaging), requiring hospitalization. 4. Hospitalized ≤48 hours. 5. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. EXCLUSION CRITERIA: 1. Underlying diseases, including chronic hypertension, diabetes mellitus, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, corticosteroids, hormonal drugs, alcohol, other antiviral and investigational medicines, and illegal drugs (during the last 30 days). 4. History of known allergy to Melatonin. 5. Pregnancy and breastfeeding. INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin capsules at a dose of 50 mg daily for a period of seven days. CONTROL GROUP: The standard therapeutic regimen for COVID-19 along with Melatonin-like placebo capsules at a dose of one capsule daily for a period of seven days. Both Melatonin and placebo capsules were prepared at the Faculty of Pharmacy and Pharmaceutical Sciences, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. MAIN OUTCOMES: The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1ß (IL-1ß), and IL-6 within seven days of randomization. The secondary outcomes are the time to improve clinical and paraclinical features along with the incidence of serious adverse drug reactions within seven days of randomization. RANDOMIZATION: Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms. BLINDING (MASKING): All study participants, clinicians, nurses, research coordinators, and those analyzing the data are blinded to the group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 60 patients randomized into two groups (30 in each group). TRIAL STATUS: The trial protocol is Version 1.0, August 14, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by November 30, 2020. TRIAL REGISTRATION: The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N5 ". The registration date was 14 August 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Betacoronavirus/drug effects , Central Nervous System Depressants/therapeutic use , Coronavirus Infections/drug therapy , Melatonin/therapeutic use , Pneumonia, Viral/drug therapy , Adult , Betacoronavirus/genetics , Biomarkers/blood , COVID-19 , Case-Control Studies , Central Nervous System Depressants/administration & dosage , Central Nervous System Depressants/adverse effects , Coronavirus Infections/diagnosis , Coronavirus Infections/virology , Double-Blind Method , Hospitalization , Humans , Iran/epidemiology , Melatonin/administration & dosage , Melatonin/adverse effects , Oxygen/blood , Pandemics , Placebos/administration & dosage , Pneumonia, Viral/diagnosis , Pneumonia, Viral/virology , SARS-CoV-2 , Safety , Time Factors , Treatment Outcome
3.
Psychosomatics ; 61(6): 585-596, 2020.
Article in English | MEDLINE | ID: covidwho-726823

ABSTRACT

BACKGROUND: The pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as one of the biggest health threats of our generation. A significant portion of patients are presenting with delirium and neuropsychiatric sequelae of the disease. Unique examination findings and responses to treatment have been identified. OBJECTIVE: In this article, we seek to provide pharmacologic and treatment recommendations specific to delirium in patients with COVID-19. METHODS: We performed a literature search reviewing the neuropsychiatric complications and treatments in prior coronavirus epidemics including Middle Eastern respiratory syndrome and severe acute respiratory syndrome coronaviruses, as well as the emerging literature regarding COVID-19. We also convened a work group of consultation-liaison psychiatrists actively managing patients with COVID-19 in our hospital. Finally, we synthesized these findings to provide preliminary pharmacologic recommendations for treating delirium in these patients. RESULTS: Delirium is frequently found in patients who test positive for COVID-19, even in the absence of respiratory symptoms. There appears to be a higher rate of agitation, myoclonus, abulia, and alogia. No data are currently available on the treatment of delirium in patients with COVID-19. Extrapolating from general delirium treatment, Middle Eastern respiratory syndrome/severe acute respiratory syndrome case reports, and our experience, preliminary recommendations for pharmacologic management have been assembled. CONCLUSIONS: COVID-19 is associated with neuropsychiatric symptoms. Low-potency neuroleptics and alpha-2 adrenergic agents may be especially useful in this setting. Further research into the pathophysiology of COVID-19 will be key in developing more targeted treatment guidelines.


Subject(s)
Adrenergic alpha-2 Receptor Agonists/therapeutic use , Antipsychotic Agents/therapeutic use , Brain Diseases/physiopathology , Coronavirus Infections/physiopathology , Delirium/drug therapy , Dopamine Agonists/therapeutic use , Pneumonia, Viral/physiopathology , Betacoronavirus , Brain Diseases/psychology , COVID-19 , Central Nervous System Depressants/therapeutic use , Coronavirus Infections/psychology , Delirium/physiopathology , Delirium/psychology , GABA Modulators/therapeutic use , Humans , Lorazepam/therapeutic use , Melatonin/therapeutic use , Pandemics , Pneumonia, Viral/psychology , Practice Guidelines as Topic , SARS-CoV-2
4.
Psychosomatics ; 61(5): 544-550, 2020.
Article in English | MEDLINE | ID: covidwho-616923
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