Trial Outcomes & Findings for Remote Treatment of Alcohol Withdrawal (NCT NCT04858490)
NCT ID: NCT04858490
Last Updated: 2026-05-14
Results Overview
Retention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
3-5 day treatment period
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Relapse to alcohol during treatment
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2
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Baseline Characteristics
Remote Treatment of Alcohol Withdrawal
Baseline characteristics by cohort
| Measure |
Symptom-triggered Diazepam Treatment
n=30 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Age, Continuous
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44.0 years
STANDARD_DEVIATION 11.3 • n=1512 Participants
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Sex: Female, Male
Female
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12 Participants
n=1512 Participants
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Sex: Female, Male
Male
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18 Participants
n=1512 Participants
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Race/Ethnicity, Customized
Ethnicity · White-European
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20 Participants
n=1512 Participants
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Race/Ethnicity, Customized
Ethnicity · Other
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10 Participants
n=1512 Participants
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Marital Status
Married/Common Law
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12 Participants
n=1512 Participants
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Marital Status
Other
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18 Participants
n=1512 Participants
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Income
> $60 000
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15 Participants
n=1512 Participants
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Income
< $60,000
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15 Participants
n=1512 Participants
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Education
Higher Education Past Secondary School
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24 Participants
n=1512 Participants
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Education
Other
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6 Participants
n=1512 Participants
|
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Prior Detoxification Experience
Yes
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13 Participants
n=1512 Participants
|
|
Prior Detoxification Experience
No
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17 Participants
n=1512 Participants
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Alcohol Use Disorders Identification Test (AUDIT)
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29.9 units on a scale
STANDARD_DEVIATION 4.2 • n=1512 Participants
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Penn Alcohol Cravings Scale (PACS)
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22.7 units on a scale
STANDARD_DEVIATION 5.4 • n=1512 Participants
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Total Standard Drinks
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263.5 Standard Drinks
STANDARD_DEVIATION 85.7 • n=1512 Participants
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Total Drinking Days
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28.1 Days
STANDARD_DEVIATION 3.5 • n=1512 Participants
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Average Standard Drinks per Drinking Day
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8.8 Standard Drinks Per Drinking Day
STANDARD_DEVIATION 2.9 • n=1512 Participants
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Binge Drinking Days
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27.1 Days
STANDARD_DEVIATION 4.8 • n=1512 Participants
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PRIMARY outcome
Timeframe: 3-5 day treatment periodRetention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol.
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=30 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Retention in Treatment
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28 Participants
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PRIMARY outcome
Timeframe: 3-5 day treatment periodTransfer 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.
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=30 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Transfer to a Higher Level of Care
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0 Participants
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SECONDARY outcome
Timeframe: Measured within 1 week of completing the remote withdrawal procedureSatisfaction with the overall treatment protocol, measured with the Client Satisfaction Questionnaire-8 (minimum score = 8; maximum score = 32; higher score indicates greater client satisfaction).
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=30 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Patient Satisfaction With the Treatment Protocol
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30.9 Score on a scale
Standard Deviation 1.5
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SECONDARY outcome
Timeframe: Measured within 1 week of completing the remote withdrawal procedureSatisfaction 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).
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=30 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Patient Satisfaction With the Telemedicine Platform
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45.1 Score on a scale
Standard Deviation 2.5
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SECONDARY outcome
Timeframe: 3-5 day treatment periodDuration of active withdrawal treatment, as measured by the number of days that patients received diazepam among patients who received benzodiazepines.
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=27 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Duration of Active Withdrawal Treatment
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2.4 days
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: 3-5 day treatment periodBenzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment.
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=30 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Requirement of Benzodiazepines
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27 Participants
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SECONDARY outcome
Timeframe: 3-5 day treatment periodDiazepam dose, as measured by the average dose of diazepam required to control symptoms among patients who received diazepam.
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=27 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Diazepam Dose
Day 1
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30 mg
Interval 10.0 to 50.0
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Diazepam Dose
Day 2
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20 mg
Interval 0.0 to 40.0
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Diazepam Dose
Day 3
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10 mg
Interval 0.0 to 20.0
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SECONDARY outcome
Timeframe: 3-5 day treatment periodWithdrawal 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).
Outcome measures
| Measure |
Symptom-triggered Diazepam Treatment
n=27 Participants
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.
Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
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|---|---|
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Withdrawal Severity
Day 1
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12.1 score on a scale
Standard Deviation 4.3
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Withdrawal Severity
Day 2
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9.4 score on a scale
Standard Deviation 4.7
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Withdrawal Severity
Day 3
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6.6 score on a scale
Standard Deviation 4.2
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Adverse Events
Symptom-triggered Diazepam Treatment
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Symptom-triggered Diazepam Treatment
n=30 participants at risk
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.
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|---|---|
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Nervous system disorders
Sedation
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63.3%
19/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Clumsiness
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16.7%
5/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Memory Loss
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10.0%
3/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Confusion
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0.00%
0/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Falls
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0.00%
0/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Seizures
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0.00%
0/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Hallucination
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0.00%
0/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Delirium
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0.00%
0/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Light-headedness
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10.0%
3/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Nervous system disorders
Dizziness
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10.0%
3/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Musculoskeletal and connective tissue disorders
Leg Weakness
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10.0%
3/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Cardiac disorders
Hypertension
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3.3%
1/30 • The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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Additional Information
Dr. Matthew E. Sloan
Centre for Addiction and Mental Health (CAMH)
Phone: 416-535-8501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place