Virtual Intensive Outpatient Program for Alcoholism

Overseen By Kelly Xiao, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Severe comorbidity, Suicidal ideation, Opioid use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual intensive outpatient program to determine its effectiveness for individuals with moderate to severe alcohol use disorder. The program replicates the structure and support of a residential treatment program but operates entirely online over four weeks. Participants engage in daily group therapy, weekly one-on-one therapy, and medication management, with daily breathalyzer checks to monitor progress. This trial may suit individuals who consume more than 10 drinks a week (for women) or 15 drinks a week (for men), wish to stop drinking during the study, and can attend online sessions from home. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options from the comfort of home.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this virtual intensive outpatient program is safe for participants?

Research has shown that intensive outpatient programs (IOPs) effectively treat alcohol and drug use problems. For many, they work just as well as inpatient care, allowing individuals to receive help without staying overnight in a clinic. Instead, therapy sessions can be attended from home.

IOPs are generally manageable for participants, with most experiencing success without significant issues. While any treatment may have side effects, IOPs are designed to ensure participant safety. They include regular therapy sessions and check-ins to monitor progress.

In virtual IOPs, participants receive support through online therapy, which includes group and individual sessions. This online format allows individuals to receive treatment from home, making the program accessible and convenient without compromising effectiveness.

Overall, IOPs, including virtual ones, have a strong record of safety and effectiveness. They provide a structured way to help individuals with alcohol use problems recover in a supportive environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Intensive Outpatient Program for alcoholism because it offers a fresh approach to treatment by being entirely virtual, making it more accessible to people who may have difficulty attending in-person sessions. Unlike traditional methods, which often require physical attendance at treatment centers, this program allows participants to receive daily psychotherapy, weekly individual therapy, and medication management right from home. Additionally, the program includes daily breathalyzer monitoring, offering real-time accountability and support. This innovative combination of virtual delivery and consistent monitoring could potentially enhance engagement and outcomes for individuals struggling with alcoholism.

What evidence suggests that this Virtual Intensive Outpatient Program is effective for alcohol use disorder?

Research has shown that intensive outpatient programs (IOPs) are as effective as inpatient treatments for many individuals with alcohol use problems. Studies have found that virtual IOPs, like the one in this trial, can be highly effective. They offer convenience and accessibility while providing structured support. Early results suggest these programs help individuals maintain sobriety through regular therapy and check-ins. Participants in this trial will receive a virtual program that includes daily group therapy, weekly one-on-one sessions, and medication management, all proven to aid in addiction treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Matthew Sloan, MD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with moderate to severe alcohol use disorder who are motivated to abstain from alcohol. Participants must attend daily virtual sessions on weekdays and take multiple breathalyzer readings each day. They need private space and OHIP coverage but can't join if they have a history of severe withdrawal, certain medical or psychiatric conditions, concurrent substance use disorders, or plans to be out of the province.

Inclusion Criteria

Access to a private location from which to participate in the program for the duration of the study

I can speak and understand English well enough to give informed consent.

I have not consumed more than the defined risky amount of alcohol in the last 60 days.

Exclusion Criteria

Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll

Currently pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study

I do not have severe health or mental health issues that would make it unsafe for me to join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week virtual intensive outpatient program with daily psychotherapy groups, weekly individual therapy, medication management, and daily breathalyzer monitoring.

4 weeks

Entirely virtual

Follow-up

Participants are monitored for safety and effectiveness after treatment with an on-site end of treatment visit and two follow-up visits at approximately day 30 and day 60.

8 weeks

3 visits (1 in-person, 2 virtual)

Aftercare

Participants may opt into an optional weekly aftercare group for approximately 2 months after completion of the virtual IOP.

8 weeks

Long-term Follow-up

Participants can complete optional follow-up sessions every 2 months for an additional 10 months following the end of the 60-day follow-up session.

10 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Intensive Outpatient Program

Trial Overview The study tests a 4-week virtual intensive outpatient program designed to help people with alcohol use disorder stop drinking. It includes group and individual therapy sessions conducted online, aiming to mimic residential treatment programs' structure and monitoring while participants remain at home.

How Is the Trial Designed?

Group I: Virtual Intensive Outpatient Program Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4152944/

Substance Abuse Intensive Outpatient Programs IOPs are an important part of the continuum of care for alcohol and drug use disorders. They are as effective as inpatient treatment for most individuals ...

2. hazeldenbettyford.org hazeldenbettyford.org/research-studies/addiction-research/virtual-intensive-outpatient-outcomes

Virtual Intensive Outpatient Outcomes: Preliminary Findings The Butler Center for Research analyzed patient data to determine the efficacy of in-person addiction treatment vs. online rehab.

3. projectcourageworks.com projectcourageworks.com/are-virtual-addiction-recovery-programs-effective/

Are Virtual Addiction Recovery Programs Effective? Yes—research and real-world outcomes show that virtual programs can be highly effective, offering convenience, accessibility, and personalized ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722922001122

Clinical Effectiveness of an Intensive Outpatient Program ... The current study describes an integrated 2-week intensive outpatient treatment (IOP) using cognitive-behavioral therapy, including prolonged exposure for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11675410/

Patient Engagement in Providing Telehealth SUD IOP ... Background: Substance use disorders (SUDs) remain a growing public health issue, with drug- and alcohol-related deaths continuing to ...

6. charliehealth.com charliehealth.com/our-approach/iop

Virtual Intensive Outpatient Program (IOP) Virtual IOP is a comprehensive mental health treatment option for people who need more than once-weekly therapy from home.

7. americanaddictioncenters.org americanaddictioncenters.org/intensive-outpatient-programs

Intensive Outpatient Program (IOP): What Is It & Find ... Read on to learn more about IOP's, including what's involved, how long intensive outpatient treatment lasts, and how to choose the best ...

8. gatewayfoundation.org gatewayfoundation.org/programs-services/levels-of-care/outpatient-programs/intensive-outpatient-program/

Intensive Outpatient Programs in Illinois Discover intensive outpatient programs at Gateway in Illinois. Get personalized addiction treatment. Start your recovery journey today!