Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4, Canada
NCT Number: NCT04858490
This study will evaluate the feasibility of delivering symptom-triggered alcohol withdrawal management by telemedicine and determine whether this intervention is satisfactory to patients.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M6J 1H4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
Other names: Valium
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 3-5 day treatment period
Benzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment.
Time frame: 3-5 day treatment period
Diazepam dose, as measured by the average dose of diazepam required to control symptoms among patients who received diazepam.
Time frame: 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).
Centre for Addiction and Mental Health
Other
Remote Treatment of Alcohol Withdrawal: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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