Remote Treatment of Alcohol Withdrawal

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04858490
Collaborator
Ontario Ministry of Health and Long Term Care (Other), Canadian Institutes of Health Research (CIHR) (Other)
30
1
1
14.2
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Remote Treatment of Alcohol Withdrawal: A Pilot Study
Actual Study Start Date :
Sep 24, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Diazepam
Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
Other Names:
  • Valium
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Secondary Outcome Measures

    1. 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).

    2. 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).

    3. 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.

    4. Requirement of benzodiazepines [3-5 day treatment period]

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

    5. 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.

    6. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Addiction and Mental Health Toronto Ontario Canada M6J 1H4

    Sponsors and Collaborators

    • Centre for Addiction and Mental Health
    • Ontario Ministry of Health and Long Term Care
    • Canadian Institutes of Health Research (CIHR)

    Investigators

    • Principal Investigator: Matthew Sloan, MD, MSc, Centre for Addiction and Mental Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre for Addiction and Mental Health
    ClinicalTrials.gov Identifier:
    NCT04858490
    Other Study ID Numbers:
    • 137/2020
    First Posted:
    Apr 26, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre for Addiction and Mental Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022