Alcohol WithdrawalNCT04858490
Remote Treatment of Alcohol Withdrawal
A study testing Diazepam in people with Alcohol Withdrawal, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Withdrawal
- What is being tested?
- Diazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2021to 21 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Treatment of Alcohol Withdrawal: A Pilot Study
This study will evaluate the feasibility of delivering symptom-triggered alcohol withdrawal management by telemedicine and determine whether this intervention is satisfactory to patients.
Read the 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.
- Conditions
- Alcohol Withdrawal
- Being tested
- Diazepam
- Keywords
- Withdrawal Management, Telemedicine, Alcohol Withdrawal, Alcohol Withdrawal Management, Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
Also called Valium
Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
| Study group | Role | What they receive |
|---|---|---|
| Symptom-triggered diazepam treatment | Experimental | 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. Receives: Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Treatment
Retention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol.
Measured: 3-5 day treatment period
Transfer to a Higher Level of Care
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.
Measured: 3-5 day treatment period
Secondary outcomes (6)
Patient Satisfaction With the Treatment Protocol
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).
Measured: Measured within 1 week of completing the remote withdrawal procedure
Patient Satisfaction With the Telemedicine Platform
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).
Measured: Measured within 1 week of completing the remote withdrawal procedure
Duration of Active Withdrawal Treatment
Duration of active withdrawal treatment, as measured by the number of days that patients received diazepam among patients who received benzodiazepines.
Measured: 3-5 day treatment period
Requirement of Benzodiazepines
Benzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment.
Measured: 3-5 day treatment period
Diazepam Dose
Diazepam dose, as measured by the average dose of diazepam required to control symptoms among patients who received diazepam.
Measured: 3-5 day treatment period
Withdrawal Severity
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).
Measured: 3-5 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start24 Sep 2021
- Primary completion16 Oct 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Matthew Sloan, MD, MSc, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858490
- Sponsor's protocol ID
- 137/2020
- Status last verified
- May 2023
- First submitted
- 20 Apr 2021
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Treatment of Alcohol Withdrawal: A Pilot Study
- ClinicalTrials.gov ID
- NCT04858490
- Acronym / sponsor ID
- 137/2020
- Conditions
- Alcohol Withdrawal
- Keywords
- Withdrawal Management, Telemedicine, Alcohol Withdrawal, Alcohol Withdrawal Management, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptom-triggered diazepam treatment | Experimental | Drug: DiazepamParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiazepamAlso: ValiumSymptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion | Drug | Symptom-triggered diazepam treatment |
Primary outcome
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.
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.
6 secondary outcomes
Patient Satisfaction With the Treatment Protocol
Time frame: Measured within 1 week of completing the remote withdrawal procedure
Patient Satisfaction With the Telemedicine Platform
Time frame: Measured within 1 week of completing the remote withdrawal procedure
Duration of Active Withdrawal Treatment
Time frame: 3-5 day treatment period
Requirement of Benzodiazepines
Time frame: 3-5 day treatment period
Diazepam Dose
Time frame: 3-5 day treatment period
Withdrawal Severity
Time frame: 3-5 day treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Sloan, MD, MSc principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diazepam in people with Alcohol Withdrawal, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in Treatment (time frame: 3-5 day treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.