Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

NCT ID: NCT05722483

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Intensive Outpatient Program

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Sloan, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kelly Xiao, MSc

Role: CONTACT

Kelly.Xiao@camh.ca

416-535-8501 ext. 32447

Facility Contacts

Kelly Xiao, BSc

Role: primary

416-535-8501 ext. 32447

Other Identifiers

055/2022

Identifier Type: -

Identifier Source: org_study_id