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

Trial Summary

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 data supports the effectiveness of the treatment Managing Physical Reactions to Overwhelming Emotions (IMPROVE) for alcohol consumption and opioid use disorder?

Research on computer-assisted therapy (CAT) for opioid use disorder shows it can reduce opioid use and improve overall functioning, suggesting that virtual therapies like IMPROVE might also be effective. Additionally, a study on mindful body awareness training, which shares elements with IMPROVE, showed increased self-awareness and positive feedback, indicating potential benefits for managing emotions and substance use. ^{1 2 3 4 5}

Is virtual therapy for alcohol and opioid use disorder safe for humans?

Research shows that digital therapies for substance use disorders, including alcohol and opioid use, are generally safe. Studies found no significant difference in adverse events (unwanted side effects) between those using digital therapy and those receiving usual treatment. ^{2 6 7 8 9}

How is the IMPROVE treatment different from other treatments for alcohol and opioid use disorders?

The IMPROVE treatment is unique because it uses virtual therapy to help manage physical reactions to overwhelming emotions, which is not a standard approach for alcohol and opioid use disorders. This method offers a novel way to provide personalized and realistic exposure to triggering scenarios, potentially enhancing emotional regulation and coping skills. ^{1 2 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: * Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence? * Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence. Participants will: * Complete a baseline electroencephalography (EEG) and self-report questionnaires. * Complete three one-hour intervention sessions (IMPROVE or control) each one week a part. * Complete a post-intervention EEG and self-report questionnaires. * Complete five ecological momentary assessment (EMA) surveys a day for 21 days. * Complete self-report questionnaires one-month after their last intervention session.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

3. England pubmed.ncbi.nlm.nih.gov

High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

What Do You Say Before You Relapse? How Language Use in a Peer-to-peer Online Discussion Forum Predicts Risky Drinking among Those in Recovery. [2019]

5. United States 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. [2021]

6. England 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Outcomes of an Integrated Telemedicine Intervention Combining Naltrexone and Cognitive Behavioral Therapy for Alcohol Use Disorder. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. [2022]

9. United States 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. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Views of Practitioners and Researchers on the Use of Virtual Reality in Treatments for Substance Use Disorders. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A Virtual Reality Meditative Intervention Modulates Pain and the Pain Neuromatrix in Patients with Opioid Use Disorder. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Effects of baseline problematic alcohol and drug use on internet-based cognitive behavioral therapy outcomes for depression, panic disorder and social anxiety disorder. [2021]