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

NCT05438641 | Completed FDA Drug

• 1 other identifier: 25510
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Withdrawal Syndrome

Keywords

Alcohol withdrawal; withdrawal seizures; DT; delirium tremens; rum fits; the shakes

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline to month 6

Secondary Outcomes (1)

• Treatment Safety

  Up to 6 months

Study Arms (2)

Conventional Benzodiazepine-based treatment group

Conventional Benzodiazepine-based group includes any subject primarily treated with BZDP agents (e.g., diazepam, lorazepam, chlordiazepoxide).

Drug: BZDP-Based Protocol

Benzodiazepine-Sparing

BZDP-Sparing group includes subjects primarily treated with a non-BZDP agent (e.g., Alpha-2 agonists and/or anticonvulsants).

Drug: BZDP-Sparing Protocol

Interventions

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.

Benzodiazepine-Sparing

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.

Also known as: Conventional Treatment

Conventional Benzodiazepine-based treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be 18 year old and older patients treated at Stanford Hospital for AWS by CL Psychiatry. The subjects will be of both genders and any ethnic background.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Alcohol Withdrawal Delirium; Alcohol Withdrawal Seizures; Tremor

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose Maldonado, MD

  Stanford University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: June 30, 2022
• Study Start: August 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

US (1)