Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

NCT05722483 | Completed

• 1 other identifier: 055/2022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder; Telemedicine; Cognitive Behavioral Therapy; Dialectical Behavior Therapy

Outcome Measures

Primary Outcomes (2)

• Retention in treatment

  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)

  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 Outcomes (11)

• Satisfaction with Telemedicine Delivery as Assessed by a modified version of the Telehealth Satisfaction Scale (TESS)

  28 days

• Changes in Number of Abstinence Days During the IOP Assessed by the Timeline Followback Interview (TLFB)

  28 days

• Changes in Number of Binge Drinking Days During the IOP Assessed by the Timeline Followback Interview (TLFB)

  28 days

• Changes in Average Drinks Per Day During the IOP Assessed by the Timeline Followback Interview (TLFB)

  28 days

• Change in Self-Reported Alcohol Craving During the IOP Assessed by the Penn Alcohol Craving Scale (PACS)

  28 days

Study Arms (1)

Virtual Intensive Outpatient Program

EXPERIMENTAL

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

Interventions

Virtual Intensive Outpatient Program OTHER

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.

Virtual Intensive Outpatient Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Able to communicate and provide informed consent in English
• Diagnosis of moderate to severe AUD, based on the Structured Clinical Interview for DSM-5, Research Version (SCID-5-RV)
• 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.
• Motivated to abstain from alcohol for the month-long treatment period (longer-term harm reduction goals are permitted)
• Access to a private location from which to participate in the program for the duration of the study.
• 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.
• Enrolled in the Ontario Health Insurance Plan (OHIP)

You may not qualify if:

• Severe medical or psychiatric comorbidity that would prevent safe participation in the study
• Active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month.
• History of alcohol withdrawal delirium
• Currently pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study.
• Enrollment in another study that conflicts with the procedures or scientific integrity of this study
• Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Matthew Sloan, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 10, 2023
• Study Start: January 30, 2023
• Primary Completion: May 26, 2025
• Study Completion: July 31, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)