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Completed

NCT Number: NCT04858490

Remote Treatment of Alcohol Withdrawal

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diazepam

Drug

Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion

Other names: Valium

Primary outcomes

  1. Retention in Treatment

    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.

  2. Transfer to a Higher Level of Care

    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.

Secondary outcomes

  1. Patient Satisfaction With the Treatment Protocol

    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).

  2. Patient Satisfaction With the Telemedicine Platform

    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).

  3. Duration of Active Withdrawal Treatment

    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.

  4. Requirement of Benzodiazepines

    Time frame: 3-5 day treatment period

    Benzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment.

  5. Diazepam Dose

    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.

  6. Withdrawal Severity

    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).

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Ontario Ministry of Health and Long Term Care

Registry information

Official study title

Remote Treatment of Alcohol Withdrawal: A Pilot Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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