What side effects are associated with this type of intervention?

Common treatments for Substance Use Disorder (SUD) include Cognitive Behavioral Therapy (CBT), Motivational Enhancement Therapy (MET), and technology-enhanced interventions such as online CBT and VR-based therapies. Side effects of these behavioral therapies are generally minimal but can include temporary increases in anxiety or distress as patients confront their substance use issues. Pharmacological treatments, often used alongside behavioral therapies, can have more pronounced side effects. For example, topiramate may cause impaired concentration, confusion, dizziness, and anxiety, while varenicline can lead to neuropsychiatric symptoms such as anxiety, depression, and agitation. Combining these treatments with behavioral interventions like VR therapy aims to enhance efficacy while managing side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorder, including methadone, buprenorphine, and naltrexone for opioid use disorder, and disulfiram, acamprosate, and naltrexone for alcohol use disorder. While the provided context does not mention specific FDA approvals for treatments similar to the VR intervention, it does highlight the use of behavioral therapies such as Cognitive Behavioral Therapy (CBT) and Motivational Enhancement Therapy (MET) in conjunction with medications like topiramate and varenicline for cannabis use disorder. These therapies aim to modify behavior and enhance motivation, which aligns with the goals of the VR intervention being studied.

What other types of research exist?

Promising novel alternatives to VR intervention for Substance Use Disorder patients include: 1) Cognitive-Behavioral Therapy (CBT) combined with contingency management, which has shown efficacy in increasing abstinence rates. 2) Digital therapeutics, such as smartphone-assisted self-help programs, which provide accessible and scalable treatment options. 3) Psilocybin-assisted psychotherapy, which has demonstrated potential in treating treatment-resistant depression and may offer benefits for SUD. 4) Trigeminal nerve stimulation, a non-invasive neuromodulation technique that has shown promise in treating ADHD and may be applicable to SUD.

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Virtual Reality for Substance Use Disorders (RENTS Trial)

N/A

Recruiting

Led By Brandon G Oberlin, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study day visit; 30-day follow-up visit; 6-month follow-up visit.

Awards & highlights

Summary

This trial uses virtual reality technology to help people in early recovery from stimulant addiction. The VR sessions aim to reduce drug use by promoting positive future thinking and encouraging delayed gratification.

Who is the study for?

This trial is for adults over 18 who have been abstinent from stimulants for at least 14 days but no more than 6 months, are committed to recovery, and can understand English. They must be outpatients possibly taking psychotropic drugs for substance use disorder-related issues and sober from drugs/alcohol for at least 24 hours before study visits.

What is being tested?

Researchers are testing a virtual reality intervention to see if it helps people with stimulant use disorders by reducing their drug use days, increasing abstinence periods, boosting future self-identification, enhancing the ability to wait for rewards, and improving perspective on the future.

What are the potential side effects?

Since this trial involves virtual reality technology rather than medication or invasive procedures, side effects may include discomfort like dizziness or nausea related to VR usage but are generally expected to be minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study day visit; 30-day follow-up visit; 6-month follow-up visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study day visit; 30-day follow-up visit; 6-month follow-up visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and study day visit; 30-day follow-up visit; 6-month follow-up visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Delayed Reward Preference

Future Self-identification

Future Time Perspective

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Virtual RealityExperimental Treatment1 Intervention

Participants in this arm will receive the following interventions: Virtual Reality Park Virtual Reality Avatar

Group II: Treatment As UsualPlacebo Group1 Intervention

Participants in this arm will receive the following interventions: Virtual Reality Park

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality

2017

Completed Phase 3

~1580

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Substance Use Disorder (SUD) often involve behavioral modification therapies, such as Cognitive-Behavioral Therapy (CBT) and Virtual Reality (VR) interventions. These treatments work by altering the cognitive and behavioral patterns that contribute to substance use. VR interventions, in particular, immerse patients in controlled, simulated environments where they can safely confront and manage triggers and cravings. This immersive experience helps patients develop effective coping strategies and resilience, which are essential for long-term recovery and reducing relapse rates. By addressing the underlying psychological factors of addiction, these therapies promote sustained abstinence and improved overall mental health.

Virtual Reality to Support Inpatient Addiction Treatment: Patients Are Ready, What About Therapists? A Feasibility Study.A Motion-Activated Video Game for Prevention of Substance Use Disorder Relapse in Youth: Pilot Randomized Controlled Trial.A Randomised Controlled Comparison of Second-Level Treatment Approaches for Treatment-Resistant Adults with Bulimia Nervosa and Binge Eating Disorder: Assessing the Benefits of Virtual Reality Cue Exposure Therapy.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

1,019 Previous Clinical Trials

1,114,127 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,543 Previous Clinical Trials

3,249,288 Total Patients Enrolled

Brandon G Oberlin, PhDPrincipal InvestigatorIndiana University

3 Previous Clinical Trials

798 Total Patients Enrolled

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT05835921 — N/A

Substance Use Disorder Research Study Groups: Virtual Reality, Treatment As Usual

Substance Use Disorder Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT05835921 — N/A

Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT05835921 — N/A

~45 spots leftby May 2026

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