Status:
COMPLETED
Remote Treatment of Alcohol Withdrawal
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Conditions:
Alcohol Withdrawal
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed 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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04858490
Start Date
September 24 2021
End Date
November 21 2023
Last Update
February 13 2024
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4