Remote Treatment of Alcohol Withdrawal

NCT04858490 | Completed

• 1 other identifier: 137/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the feasibility of delivering symptom-triggered alcohol withdrawal management by telemedicine and determine whether this intervention is satisfactory to patients.

Conditions

Alcohol Withdrawal

Keywords

Withdrawal Management; Telemedicine; Alcohol Withdrawal; Alcohol Withdrawal Management; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Retention in treatment

  Retention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol.

  3-5 day treatment period

• Transfer to a higher level of care

  Transfer to a higher level of care, as measured by the percentage of participants sent to the emergency room due to complications, need for intensive monitoring, or acute intoxication.

  3-5 day treatment period

Secondary Outcomes (6)

• Patient satisfaction with the treatment protocol

  Measured within 1 week of completing the remote withdrawal procedure

• Patient satisfaction with the telemedicine platform

  Measured within 1 week of completing the remote withdrawal procedure

• Duration of active withdrawal treatment

  3-5 day treatment period

• Requirement of benzodiazepines

  3-5 day treatment period

• Diazepam dose

  3-5 day treatment period

Study Arms (1)

Symptom-triggered diazepam treatment

EXPERIMENTAL

Participants will be treated for a period of 3 days using a symptom-triggered withdrawal management protocol delivered over telemedicine. Participants who score 10 or above on the modified CIWA-Ar will be advised to take a specific dose of diazepam (either 10 or 20mg, at the clinician's discretion). Participants will be reassessed regularly over the 3-day period.

Drug: Diazepam

Interventions

Diazepam DRUG

Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion

Also known as: Valium

Symptom-triggered diazepam treatment

Eligibility Criteria

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

You may qualify if:

• Adults 18 years and older
• Are actively using alcohol
• Previously met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) B criteria for alcohol withdrawal
• Aim to achieve at least 30 days of abstinence as a treatment goal following initiation of remote alcohol withdrawal management
• Are able to provide informed consent in English.
• Reside or are able to stay at an address within 2-hours travelling distance from the Centre for Addiction and Mental Health for the entire duration of the remote withdrawal procedure
• Are enrolled in the Ontario Health Insurance Plan (OHIP)

You may not qualify if:

• History of complicated withdrawal including withdrawal seizures, hallucinosis, or delirium
• Positive UDS for sedatives or opioids, currently prescribed sedatives or opioids, or diagnosis of sedative-hypnotic or opioid use disorder within the past year (based on assessment). Individuals prescribed low doses of benzodiazepines (e.g. lorazepam 1mg PO daily) or with a positive urine benzodiazepine screen that is not thought to be due to benzodiazepine misuse may be permitted to proceed with the study at the discretion of the study physician.
• Severe medical or psychiatric comorbidity that would prevent safe participation in the study
• Contraindications to the safe use of diazepam including: known hypersensitivity to diazepam severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome, acute narrow-angle glaucoma, and myasthenia gravis. Individuals with sleep apnea may be permitted to proceed with the study at the discretion of the study physician.
• Active withdrawal symptoms (CIWA-Ar \> 12) at the time of the eligibility assessment
• Active suicidal ideation at the time of eligibility assessment
• Positive urine pregnancy test, actively breastfeeding, or planning to become pregnant or breastfeed during the study period
• Lack of stable housing
• Enrollment in another study that conflicts with the procedures or scientific integrity of this study

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Ontario Ministry of Health and Long Term Care: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Matthew Sloan, MD, MSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 26, 2021
• Study Start: September 24, 2021
• Primary Completion: October 16, 2023
• Study Completion: November 21, 2023
• Last Updated: February 13, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)