Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-09-24
2023-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Symptom-triggered diazepam treatment
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.
Diazepam
Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
Interventions
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Diazepam
Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ontario Ministry of Health and Long Term Care
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Centre for Addiction and Mental Health
OTHER
Responsible Party
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Principal Investigators
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Matthew Sloan, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Other Identifiers
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137/2020
Identifier Type: -
Identifier Source: org_study_id
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