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

Retrospective Chart Review of 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.

Study Overview

• Status: Completed
• Conditions: Alcohol Withdrawal Syndrome
• Intervention / Treatment: Drug: BZDP-Based Protocol; Drug: BZDP-Sparing Protocol

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Safety	Presence and nature of adverse reactions	Up to 6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jose Maldonado, MD, Stanford University Department of Psychiatry

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: delirium tremens; Alcohol withdrawal; withdrawal seizures; DT; rum fits; the shakes
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Syndrome; Substance Withdrawal Syndrome
• Other Study ID Numbers: 25510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No