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NCT Number: NCT05438641

Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants

Complicated alcohol withdrawal syndrome (AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist and/or anticonvulsant agents; all currently being used for the management of other medical conditions. This project intends to collect and analyze the data of all subjects managed with this approach to better understand its effectiveness and assess for potential adverse effects.

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Key information

Conditions

Alcohol Withdrawal Syndrome Alcohol Withdrawal Delirium Alcohol Withdrawal Seizures Alcohol-Induced Disorders Alcohol-Induced Disorders, Nervous System Alcohol-Related Disorders Chemically-Induced Disorders Dyskinesias Mental Disorders Nervous System Diseases Neurologic Manifestations Neurotoxicity Syndromes Pathological Conditions, Signs and Symptoms Poisoning Seizures Signs and Symptoms Substance Withdrawal Syndrome Substance-Related Disorders Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

About this study

Complicated alcohol withdrawal syndrome (C-AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist (e.g., clonidine, guanfacine, dexmedetomidine) and/or anticonvulsant agents (e.g., gabapentin, valproic acid, carbamazepine); all currently being used for the management of other medical conditions. The proposed study consists of an exhaustive chart review of these records to better understand the safety and effectiveness of alpha-2 agonists and anticonvulsants in the prophylaxis and treatment of AWS. Specifically the investigators want to understand the time to resolution of AWS symptoms, whether there are any limiting side effects to this regimen, and the need of for rescue with benzodiazepine agents. The information obtained from this study will be very helpful in assisting in the design of safer and more effective treatment of AWS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the cases referred to the Psychosomatic Medicine Service for assistance with prophylactic or symptomatic management of AWS starting 8/1/2011 until 8/31/2014.

Exclusion criteria

  • Patients who through chart review were found to have been primarily suffering from delirium from causes other than AWS.

Treatment and study plan

BZDP-Sparing Protocol

Drug

BZDP-Sparing group includes subjects primarily treated with a non-BZDP agent (e.g., Alpha-2 agonists and/or anticonvulsants). Rescue with BZDP-based treatment allowed if there is symptomatic breakthrough- as measured by CIWA > 15.

BZDP-Based Protocol

Drug

Patients in this arm will received active treatment based on conventional BZDP-based protocol; additional BZDP are permitted for patients who are still symptomatic, based on CIWA-Protocol.

Other names: Conventional Treatment

Primary outcomes

  1. Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score

    Time frame: Baseline to month 6

    The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).

Secondary outcomes

  1. Treatment Safety

    Time frame: Up to 6 months

    Presence and nature of adverse reactions

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Retrospective Chart Review of Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2022
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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