Remote Treatment of Alcohol Withdrawal

Alcohol Withdrawal Clinical Trial

Official title:

Remote Treatment of Alcohol Withdrawal: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858490
• Other study ID #: 137/2020
• Status: Completed
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: November 21, 2023

Study information

• Verified date: May 2023
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This single-arm pilot feasibility study will recruit actively drinking participants with a history of alcohol withdrawal in order to provide remotely monitored symptom-triggered alcohol withdrawal treatment using telemedicine. Participants will initially complete a screening and eligibility visit. If eligible, participants will then be scheduled for 3-day remote withdrawal management (which can be extended by 1-2 days if medically indicated). During remote withdrawal management, participants will receive symptom-triggered diazepam treatment using a modified version of the Clinical Institute Withdrawal Assessment for Alcohol Scale, revised (CIWA-Ar). Within one week following termination of withdrawal treatment, participants will be scheduled for a remote follow up visit in which they will complete patient satisfaction questionnaires and will be offered weekly counselling sessions and anticraving medication to prevent relapse to alcohol use. Approximately 30 days following treatment initiation, relapse to alcohol use will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 21, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alcohol Withdrawal

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient satisfaction with the treatment protocol	Satisfaction with the overall treatment protocol, measured with the Client Satisfaction Questionnaire-8 (minimum score = 8; maximum score = 32; higher score indicates greater client satisfaction).	Measured within 1 week of completing the remote withdrawal procedure
Secondary	Patient satisfaction with the telemedicine platform	Satisfaction with the telemedicine platform, measured with a modified version of the Telehealth Satisfaction Scale (minimum score = 12; maximum score = 48; higher score indicates greater satisfaction with the telemedicine platform).	Measured within 1 week of completing the remote withdrawal procedure
Secondary	Duration of active withdrawal treatment	Duration of active withdrawal treatment, as measured by the number of days that patients received diazepam among patients who received benzodiazepines.	3-5 day treatment period
Secondary	Requirement of benzodiazepines	Benzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment.	3-5 day treatment period
Secondary	Diazepam dose	Diazepam dose, as measured by the average dose of diazepam required to control symptoms among patients who received diazepam.	3-5 day treatment period
Secondary	Withdrawal severity	Withdrawal severity, as measured by the average peak Clinical Institute Withdrawal Assessment for Alcohol Scale, revised score measured over the treatment period (minimum score = 0; maximum score = 67; higher score indicates greater withdrawal severity).	3-5 day treatment period