Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

March 19, 2026 updated by: Centre for Addiction and Mental Health
This single-arm pilot study will recruit participants with moderate to severe alcohol use disorder for a 4-week virtual intensive outpatient program (IOP). The program aims to replicate the structure and abstinence monitoring of a residential treatment program although the program is delivered entirely virtually.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pragmatic single-arm pilot study will recruit participants with moderate to severe alcohol use disorder who are seeking abstinence for a virtual intensive outpatient program (virtual IOP) The IOP will take place primarily over a 4 week period. Components of the program include a cognitive behavioral therapy for alcohol use disorder group (12 sessions), a DBT skills group (12 sessions), a Health and Wellness group (8 sessions), weekly individual therapy, weekly medication management appointments, and abstinence monitoring multiple times per day using breathalyzers equipped with facial recognition and internet connectivity. Following completion of the program, participants will complete an on-site end of treatment visit and two follow up visits at approximately day 30 and day 60 following termination of the virtual IOP. Participants will be offered the opportunity to participate in an optional weekly aftercare group for approximately 2 months after completion of the virtual IOP. Interested participants will also be able to complete optional follow-up sessions every 2 months for an additional 10 months following the end of the 60-day follow-up session.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Able to communicate and provide informed consent in English
  3. Diagnosis of moderate to severe AUD, based on the Structured Clinical Interview for DSM-5, Research Version (SCID-5-RV)
  4. Risky alcohol consumption, defined as > 10 drinks per week for females and > 15 drinks for males on average during the 60 days prior to the eligibility assessment.
  5. Motivated to abstain from alcohol for the month-long treatment period (longer-term harm reduction goals are permitted)
  6. Access to a private location from which to participate in the program for the duration of the study.
  7. Able and motivated to complete all aspects of the program, including attending all virtual intensive outpatient program sessions (this includes being available for group and individual sessions throughout the day on weekdays) and completing multiple daily breathalyzer readings throughout the entire program. Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll.
  8. Enrolled in the Ontario Health Insurance Plan (OHIP)

Exclusion Criteria:

  1. Severe medical or psychiatric comorbidity that would prevent safe participation in the study
  2. Active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month.
  3. Diagnosis of opioid use disorder or sedative use disorder within the past year based on the SCID-5 (other concurrent substance use disorders such as cannabis use disorder will not be exclusionary)
  4. History of alcohol withdrawal delirium
  5. Currently pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study.
  6. Enrollment in another study that conflicts with the procedures or scientific integrity of this study
  7. Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Intensive Outpatient Program
Participants will be treated in a 4 week program involving daily psychotherapy groups, weekly individual therapy and medication management, as well as daily breathalyzer monitoring.
Other: Virtual Intensive Outpatient Program
Components of the intervention include a cognitive behavioral therapy for alcohol use disorder group (12 sessions), a DBT skills group (12 sessions), a Health and Wellness group (8 sessions), weekly individual therapy, weekly medication management appointments, and abstinence monitoring multiple times per day using breathalyzers equipped with facial recognition and internet connectivity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Retention in treatment
Time Frame: 28 Days
Proportion of study participants that complete the entire IOP. Dropouts will include (1) individuals who miss two of the first three days of group therapy or (2) individuals who miss > 5 total days of group therapy (i.e. over 25% of the program) or (3) Participants who do not complete their breathalyzer monitoring for over 25% of the study (e.g., miss readings on > 7 days, with some exceptions). Our target retention rate to demonstrate feasibility is ≥ 50% of participants (participants who do not show up to any groups will not be included in this or other analyses).
28 Days
Satisfaction with treatment as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: 28 days
Measures overall satisfaction with the treatment program (minimum score = 8; maximum score = 32; higher score indicates greater client satisfaction). Client satisfaction ratings in the good to excellent range (20-32) will be considered as strong evidence of acceptable levels of satisfaction with the intervention. This will be our primary measure of client satisfaction.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with Telemedicine Delivery as Assessed by a modified version of the Telehealth Satisfaction Scale (TESS)
Time Frame: 28 days
Measures satisfaction with the telehealth platform and service delivery over telehealth (minimum score = 12; maximum score = 48; higher score indicates greater satisfaction with the telemedicine platform).
28 days
Changes in Number of Abstinence Days During the IOP Assessed by the Timeline Followback Interview (TLFB)
Time Frame: 28 days
Number of days in which individuals did not consume any alcohol.
28 days
Changes in Number of Binge Drinking Days During the IOP Assessed by the Timeline Followback Interview (TLFB)
Time Frame: 28 days
Number of binge drinking days (4+ drinks for females, 5+ drinks for males)
28 days
Change in Self-Reported Alcohol Craving During the IOP Assessed by the Penn Alcohol Craving Scale (PACS)
Time Frame: 28 days
Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving.
28 days
Change in Quality of Life during the IOP Assessed Using the Abbreviated World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time Frame: 28 days
Measures quality of life (scores are transformed to 0-100; higher scores indicate higher quality of life).
28 days
Change in Depressive Symptoms during the IOP Assessed Using the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 28 days
Measures depressive symptoms (minimum score = 0; maximum score = 27; higher scores indicate higher levels of depressive symptoms).
28 days
Change in Anxiety Symptoms during the IOP Assessed Using the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 28 days
Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety)
28 days
Change in Sleep during the IOP Assessed Using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 28 days
Measures quality of sleep (minimum score = 0; maximum score = 21; higher scores indicate lower quality of sleep).
28 days
Change in Emotion Regulation During the IOP Assessed Using the Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 28 days
Measures difficulties in emotion regulation (minimum score = 36; maximum score = 180; higher scores indicate more difficulties in emotion regulation)
28 days
Change in Emotion Regulation During the IOP Assessed Using the Emotion Regulation Questionnaire (ERQ)
Time Frame: 28 days
Measures cognitive reappraisal (minimum score = 6; maximum score = 42; higher score indicates more frequent use of reappraisal) and expressive suppression (minimum score = 4; maximum score = 28; higher scores indicate more frequent use of suppression).
28 days
Changes in Average Drinks Per Day During the IOP Assessed by the Timeline Followback Interview (TLFB)
Time Frame: 28 days
Average Drinks Per Day
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Sloan, MD, Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 055/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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