Clinical trial NCT04858490: Remote Treatment of Alcohol Withdrawal
Official title: Remote Treatment of Alcohol Withdrawal: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Withdrawal
Keywords: Withdrawal Management
Telemedicine
Alcohol Withdrawal
Alcohol Withdrawal Management
Alcohol Use Disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention in treatment
timeFrame: 3-5 day treatment period
measure: Transfer to a higher level of care
timeFrame: 3-5 day treatment period
Secondary outcomes:
measure: Patient satisfaction with the treatment protocol
timeFrame: Measured within 1 week of completing the remote withdrawal procedure
measure: Patient satisfaction with the telemedicine platform
timeFrame: Measured within 1 week of completing the remote withdrawal procedure
measure: Duration of active withdrawal treatment
timeFrame: 3-5 day treatment period
measure: Requirement of benzodiazepines
timeFrame: 3-5 day treatment period
measure: Diazepam dose
timeFrame: 3-5 day treatment period
measure: Withdrawal severity
timeFrame: 3-5 day treatment period
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Matthew Sloan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: