Alcohol Withdrawal
Conditions
Keywords
Withdrawal Management, Telemedicine, Alcohol Withdrawal, Alcohol Withdrawal Management, Alcohol Use Disorder
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.
Interventions
DRUGDiazepam
Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
Sponsors
Centre for Addiction and Mental Health
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in Treatment | 3-5 day treatment period | Retention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol. |
| Transfer to a Higher Level of Care | 3-5 day treatment period | 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. If ≤ 20%, of participants require transfer to a higher level of care, we will consider this as additional evidence of feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With the Treatment Protocol | Measured within 1 week of completing the remote withdrawal procedure | 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). |
| Patient Satisfaction With the Telemedicine Platform | Measured within 1 week of completing the remote withdrawal procedure | 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). |
| Duration of Active Withdrawal Treatment | 3-5 day treatment period | Duration of active withdrawal treatment, as measured by the number of days that patients received diazepam among patients who received benzodiazepines. |
| Requirement of Benzodiazepines | 3-5 day treatment period | Benzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment. |
| Diazepam Dose | 3-5 day treatment period | Diazepam dose, as measured by the average dose of diazepam required to control symptoms among patients who received diazepam. |
| Withdrawal Severity | 3-5 day treatment period | 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). |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMatthew Sloan, MD, MSc
Centre for Addiction and Mental Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.0 years STANDARD_DEVIATION 11.3 |
| Alcohol Use Disorders Identification Test (AUDIT) | 29.9 units on a scale STANDARD_DEVIATION 4.2 |
| Average Standard Drinks per Drinking Day | 8.8 Standard Drinks Per Drinking Day STANDARD_DEVIATION 2.9 |
| Binge Drinking Days | 27.1 Days STANDARD_DEVIATION 4.8 |
| Education Higher Education Past Secondary School | 24 Participants |
| Education Other | 6 Participants |
| Income < $60,000 | 15 Participants |
| Income > $60 000 | 15 Participants |
| Marital Status Married/Common Law | 12 Participants |
| Marital Status Other | 18 Participants |
| Penn Alcohol Cravings Scale (PACS) | 22.7 units on a scale STANDARD_DEVIATION 5.4 |
| Prior Detoxification Experience No | 17 Participants |
| Prior Detoxification Experience Yes | 13 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 10 Participants |
| Race/Ethnicity, Customized Ethnicity White-European | 20 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
| Total Drinking Days | 28.1 Days STANDARD_DEVIATION 3.5 |
| Total Standard Drinks | 263.5 Standard Drinks STANDARD_DEVIATION 85.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 22 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed