Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

Last updated: February 9, 2024
Sponsor: Centre for Addiction and Mental Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Addictions

Alcohol Dependence

Substance Abuse

Treatment

Virtual Intensive Outpatient Program

Clinical Study ID

NCT05722483
055/2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 forDSM-5, Research Version (SCID-5-RV)
  4. Risky alcohol consumption, defined as > 10 drinks per week for females and > 15 drinksfor 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-termharm reduction goals are permitted)
  6. Access to a private location from which to participate in the program for the durationof the study.
  7. Able and motivated to complete all aspects of the program, including attending allvirtual intensive outpatient program sessions (this includes being available for groupand individual sessions throughout the day on weekdays) and completing multiple dailybreathalyzer readings throughout the entire program. Individuals planning to be out ofthe province during the virtual intensive outpatient program will not be permitted toenroll.
  8. Enrolled in the Ontario Health Insurance Plan (OHIP)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 63
Treatment Group(s): 1
Primary Treatment: Virtual Intensive Outpatient Program
Phase:
Study Start date:
January 30, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Centre for Addiction and Mental Health

    Toronto, Ontario M6J 1H4
    Canada

    Active - Recruiting

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