Virtual Therapy for Alcohol Consumption and Opioid Use Disorder

Recruiting at 1 trial location

Overseen By Stephanie Gorka, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University

Must be taking: Opioid use disorder medications

Disqualifiers: Psychosis, Mania, Intoxication, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual therapy called IMPROVE, designed to help individuals with anxiety and uncertainty reduce heavy drinking while adhering to their medication for opioid use disorder (MOUD). The study compares IMPROVE to a general health education program to determine which better supports these goals. Ideal candidates for the trial have recently started an outpatient MOUD program and consume a high amount of alcohol weekly. Participants will engage in several therapy sessions and provide feedback through surveys and other assessments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective therapy.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, since participants must be enrolled in a medication for opioid use disorder (MOUD) program, it seems you should continue with those medications.

What prior data suggests that the IMPROVE intervention is safe for participants?

Research has shown that cognitive behavioral therapy (CBT) effectively treats drug and alcohol problems. IMPROVE, the treatment tested in this trial, is a type of therapy that helps people change their thoughts and behaviors to better manage emotions and reduce substance use.

These therapies are generally easy for people to handle, with few serious side effects reported. Since this trial is in Phase 2, earlier studies have demonstrated that the treatment is somewhat safe. Participants might find IMPROVE a promising and safe option for managing alcohol and opioid use disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IMPROVE protocol because it offers a fresh approach to managing alcohol consumption and opioid use disorder by directly targeting anxiety and uncertainty. Unlike standard treatments that often focus on medication or broad-based counseling, IMPROVE is a clinician-delivered method that aims to help individuals manage their physical reactions to overwhelming emotions. This novel focus on emotional regulation could provide a powerful tool for those struggling with addiction, offering a more tailored and potentially effective way to address the psychological triggers of substance use.

What evidence suggests that the IMPROVE intervention could be effective for reducing alcohol consumption and enhancing MOUD outcomes?

Research shows that people with substance use problems often struggle to manage their emotions. In this trial, participants in one arm will receive the IMPROVE program, which helps individuals handle strong feelings, particularly anxiety and uncertainty. The program uses Cognitive Behavioral Therapy (CBT) techniques, proven to treat drug and alcohol problems. Studies indicate that these methods can reduce substance use and help individuals adhere to other treatments. By focusing on emotion management, IMPROVE aims to support those taking medication for opioid use disorder (MOUD) and reduce heavy drinking. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are currently receiving medication for opioid use disorder (MOUD) and struggle with heavy drinking. Participants must be willing to undergo brain wave testing (EEG), answer questionnaires, attend three one-hour virtual sessions over three weeks, and complete daily surveys for 21 days.

Inclusion Criteria

Can read and comprehend English

Enrolled in outpatient MOUD program (within the past month)

Heavy alcohol user defined using the NIAAA criteria (i.e., consume 8+/15+ drinks per week [women/men] with at least two binge episodes [4/5+ drinks for women/men in a 2 hour period] in the past month)

Exclusion Criteria

I am able to understand and make decisions about my health care.

Current comorbid moderate to severe substance use disorder other than alcohol and opioids

Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline electroencephalography (EEG) and self-report questionnaires

1 week

1 visit (in-person)

Intervention

Participants complete three one-hour intervention sessions (IMPROVE or control) each one week apart

3 weeks

3 visits (virtual)

Post-Intervention Assessment

Participants complete a post-intervention EEG and self-report questionnaires

1 week

1 visit (in-person)

Ecological Momentary Assessment

Participants complete five ecological momentary assessment (EMA) surveys a day for 21 days

3 weeks

Follow-up

Participants complete self-report questionnaires one-month after their last intervention session

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Managing Physical Reactions to Overwhelming Emotions (IMPROVE)

Trial Overview The study tests a digital psychotherapeutic intervention called IMPROVE aimed at reducing alcohol consumption and improving adherence to MOUD. It will be compared with a control group receiving health education training to see if there's a difference in outcomes.

How Is the Trial Designed?

Group I: Managing Physical Reactions to Overwhelming Emotions (IMPROVE) Experimental Treatment 1 Intervention

In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.

Group II: Health Education Training (HET) Active Control 1 Intervention

In this arm, participants will receive a clinician-delivered protocol with a digital component, called HET. HET focuses on healthy living more broadly and does not include information about anxiety or uncertainty.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Computer-based interventions for drug use disorders have shown high acceptability and can lead to reduced substance use, increased motivation to change, and better retention compared to traditional treatment methods, based on a review of 12 studies.

These interventions offer a promising alternative due to their lower cost and greater accessibility, suggesting they could significantly transform treatment approaches for drug use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. Moore, BA., Fazzino, T., Garnet, B., et al.[2022]

A study involving 166 adults with alcohol use disorder found that a therapist-guided high-intensity internet intervention did not significantly outperform an unguided low-intensity intervention in reducing alcohol consumption at the 6-month follow-up.

Both interventions had low rates of negative effects (8-14%) and deterioration (3-5%), indicating that they were relatively safe options for participants seeking help with alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. Sundström, C., Eék, N., Kraepelien, M., et al.[2021]

In a study of 97 participants with comorbid depression and substance misuse, intensive motivational interviewing and cognitive behavior therapy (MI/CBT) significantly improved depression symptoms compared to a brief intervention alone, with both live and computer-based formats showing effectiveness at the 12-month follow-up.

Computer-based therapy for depression and substance use was found to be at least as effective as live therapy, particularly in reducing cannabis use and hazardous substance use, suggesting that integrated computer-based interventions could be a viable option in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy. Kay-Lambkin, FJ., Baker, AL., Lewin, TJ., et al.[2022]

A digital therapeutic (DT) significantly increased abstinence rates among patients with substance use disorders (40.3% in the DT group vs. 17.6% in the treatment-as-usual group) over a 12-week period, indicating its efficacy in reducing substance use.

The DT also improved retention in treatment (76.2% vs. 63.2%), and importantly, there were no significant differences in adverse event rates between the DT and traditional treatment groups, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. Maricich, YA., Nunes, EV., Campbell, ANC., et al.[2022]

A 12-week virtual reality-based meditative intervention for 15 patients undergoing methadone maintenance treatment showed promising results, with significant reductions in pain, opioid cravings, anxiety, and depression after each session.

Neuroimaging results indicated that the intervention led to decreased activation in the pain-related brain region (left postcentral gyrus) and altered connectivity patterns, suggesting a potential neurobiological mechanism for the observed behavioral improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Reality Meditative Intervention Modulates Pain and the Pain Neuromatrix in Patients with Opioid Use Disorder. Faraj, MM., Lipanski, NM., Morales, A., et al.[2022]

The pilot study successfully recruited and retained 10 participants within two weeks, demonstrating the feasibility of implementing the Mindful Awareness in Body-oriented Therapy (MABT) alongside buprenorphine treatment for opioid use disorder.

Participants in the MABT group showed significant improvements in interoceptive awareness skills compared to the control group, and feedback indicated high satisfaction with the intervention, suggesting it could be a beneficial adjunct therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder. Price, CJ., Merrill, JO., McCarty, RL., et al.[2021]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

A study involving 1,107 individuals with opioid use disorder showed that engaging with the computer-assisted therapy program 'Breaking Free Online' led to significant reductions in opioid use and improvements in biopsychosocial functioning, with effect sizes ranging from 0.15 to 0.50.

Participants with greater baseline clinical impairment experienced more substantial improvements post-treatment, suggesting that CAT could be particularly beneficial for those with more complex psychosocial issues when combined with medications for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between baseline opioid use disorder severity, mental health and biopsychosocial functioning, with clinical responses to computer-assisted therapy treatment. Elison-Davies, S., Märtens, K., Yau, C., et al.[2021]

Practitioners and researchers believe that Virtual Reality Therapy (VRT) could be a valuable addition to treating Substance Use Disorders (SUDs), as it offers safe and realistic exposure to triggering scenarios.

VRT is seen as beneficial for adults and those with mental health issues, with the potential to enhance therapy by allowing the inclusion of avatars and observing reactions, although risks like relapse and over-confidence need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Practitioners and Researchers on the Use of Virtual Reality in Treatments for Substance Use Disorders. Skeva, R., Gregg, L., Jay, C., et al.[2021]

Citations

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