Virtual Reality Tool for Substance Use Disorder and HIV Risk

Overseen By Carla Danielson, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Psychosis, Cognitive disability, PDD, others

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

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a virtual reality tool might reduce risky behaviors related to HIV and substance use among young people who have faced significant challenges. The main goal is to determine if this tool can help individuals make safer health choices. Potential participants include young men attracted to men, or teens and young adults who have recently used substances, especially those who have experienced past trauma like assault or violence. Frontline healthcare workers serving these communities are also eligible. All participants must live in the Charleston, SC/Tri-county area. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new ways of supporting vulnerable communities.

Will I have to stop taking my current medications?

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

What prior data suggests that this virtual reality tool is safe for participants?

Studies have shown that virtual reality tools can be used safely in various situations, including treating substance use disorders. Research indicates that people generally tolerate these tools well, meaning they can use them without harm. For example, one study found that participants used virtual reality technology without any serious side effects. This suggests that the virtual reality tool used in this trial is likely safe. However, individual experiences may vary, so discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a Virtual Reality (VR) tool for treating Substance Use Disorder and reducing HIV risk because it offers an immersive, engaging experience that traditional therapies lack. Unlike standard treatments, such as cognitive-behavioral therapy or medication-assisted treatment, this VR tool provides a simulated environment where participants can safely practice coping strategies and decision-making in real-time scenarios. This innovative approach not only enhances learning and retention but also personalizes the experience, potentially leading to better outcomes in managing addiction and preventing high-risk behaviors associated with HIV.

What evidence suggests that this virtual reality tool is effective for substance use disorder and HIV risk?

Research has shown that virtual reality (VR) therapy can help treat substance use disorder (SUD). Various studies have found that VR tools reduce the urges and cravings that can lead to substance use. Managing these cravings is crucial for preventing substance abuse. Some research also indicates that teenagers have positive experiences using VR for alcohol prevention, suggesting it is engaging and potentially useful. Although more research is needed, these early results suggest that VR could be a promising tool for addressing SUD and related risky behaviors.

In this trial, all participants will receive the same VR intervention to further explore its effectiveness in managing SUD and HIV risk. ^{1 4 6 7 8}

Who Is on the Research Team?

Danielson

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for young people aged 13-25 who use substances, identify as young men having sex with men (YMSM), or have experienced trauma like assault. It's also for healthcare workers dealing with these groups. Participants must be sexually active or planning to be within six months.

Inclusion Criteria

I identify as a young man who has sex with men.

Have experienced at least one interpersonal traumatic event (ITE) in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)

I am sexually active or plan to be in the next 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Informed consent and baseline measures are administered

1 day

1 visit (in-person)

Virtual Reality Intervention

Participants use and assess the virtual reality tool

1 day

1 visit (in-person)

Follow-up Assessment

Baseline assessments are re-administered

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Tool

Trial Overview The study tests a virtual reality tool designed to help at-risk youth and healthcare workers address HIV risk and substance abuse following traumatic experiences. The research includes both interviews and surveys in its multi-phase approach.

How Is the Trial Designed?

Group I: Virtual Reality Experimental Treatment 1 Intervention

All participants will receive the same intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

Virtual reality therapy (VRT) was found to be highly acceptable and feasible for integration with standard addiction treatment (TAU) among both therapists and patients in a study involving 21 therapists and 113 patients over 6-12 months.

While VRT showed potential effectiveness in enhancing communication and problem-solving skills for relapse prevention, barriers such as motion sickness, technical issues, and costs were identified, indicating areas for improvement before wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality to Support Inpatient Addiction Treatment: Patients Are Ready, What About Therapists? A Feasibility Study. Arissen, C., van der Helm, L., Dijkstra, B., et al.[2022]

A pilot clinical trial involving 19 participants with cannabis use disorder and severe mental disorder showed that an innovative avatar intervention led to a significant moderate reduction in cannabis use, with a Cohen's d of 0.611, indicating effectiveness.

The intervention utilized immersive virtual reality techniques, allowing participants to practice therapeutic methods in real-time, suggesting that this novel approach could enhance treatment outcomes for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. Giguère, S., Potvin, S., Beaudoin, M., et al.[2023]

In a pilot trial with 13 nicotine-dependent participants, exposure to virtual reality (VR) smoking cues significantly increased craving intensity by an average of 118% compared to VR neutral cues.

This study suggests that VR cue reactivity can provide a standardized and controlled method for examining drug triggers, which may enhance research and treatment strategies for substance abuse and smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing virtual reality to standardize nicotine craving research: a pilot study. Bordnick, PS., Graap, KM., Copp, H., et al.[2015]

Craving is a key factor in substance use disorders (SUDs) that can lead to relapse, and traditional behavioral therapies struggle to suppress it in real-life social contexts.

Virtual reality (VR) is being explored as a tool to enhance craving-induction and cue-exposure therapy, but while it can effectively increase craving, its combination with cue-exposure therapy has shown limited success in promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of virtual reality in craving assessment and cue-exposure therapy in substance use disorders. Hone-Blanchet, A., Wensing, T., Fecteau, S.[2022]

Virtual reality (VR) therapy shows promise in reducing cravings and substance use in individuals with substance use disorder, particularly in studies focused on nicotine addiction.

While VR may help improve mood and anxiety symptoms, the results are mixed, indicating that more targeted interventions are needed to fully understand its efficacy in treating emotional dysregulation and enhancing treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of virtual reality therapies for substance use disorders: Impact on secondary treatment outcomes. Taubin, D., Berger, A., Greenwald, D., et al.[2023]

An immersive virtual reality (VR) intervention for adults in early recovery from substance use disorder (SUD) was well tolerated and showed no adverse effects, significantly increasing participants' future self-continuity and delaying reward preference, which doubled their delay tolerance.

After the VR experience, 30 days of follow-up indicated that participants who maintained a strong connection to their 'Recovery Future Self' remained abstinent, suggesting that enhancing future self-similarity can be a promising strategy for supporting SUD recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality intervention effects on future self-continuity and delayed reward preference in substance use disorder recovery: pilot study results. Shen, YI., Nelson, AJ., Oberlin, BG.[2023]

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 study involving 42 adolescents showed that a virtual reality environment (VRE) designed to simulate a party increased physiological arousal, as measured by heart rate and respiratory sinus arrhythmia, compared to a neutral VRE.

The findings suggest that VREs can effectively elicit physiological responses to cues related to substance use and sexual risk, indicating their potential utility in research and interventions targeting adolescent behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliciting affect via immersive virtual reality: a tool for adolescent risk reduction. Hadley, W., Houck, CD., Barker, DH., et al.[2021]

Ecological Momentary Assessment (EMA) technology showed high rates of reported drug use and aligned well with traditional assessment methods in studies involving 5 participants, indicating its effectiveness for monitoring drug use and HIV risk behaviors.

Technology-based interventions, including mobile apps and text messaging, are gaining interest among drug-using populations, with one trial showing significantly higher HIV testing rates, suggesting these methods may enhance access to necessary health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using technology to assess and intervene with illicit drug-using persons at risk for HIV. Horvath, KJ., Lammert, S., LeGrand, S., et al.[2019]

Virtual reality (VR) has proven effective in treating various conditions, including anxiety disorders and aiding in stroke rehabilitation, by immersing patients in controlled virtual environments.

VR is particularly useful in studying and treating addiction and obesity, as it allows researchers to simulate real-life cues and settings that trigger cravings or unhealthy eating behaviors, enhancing behavior modification strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What virtual reality research in addictions can tell us about the future of obesity assessment and treatment. Bordnick, PS., Carter, BL., Traylor, AC.[2022]

Virtual Reality (VR) technology shows promise in both assessing cravings and treating substance use disorders, providing high ecological validity in its applications.

While VR effectively provokes cravings across various addictions, treatment outcomes based solely on virtual exposure to drug-related cues have shown mixed results, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality (VR) in Assessment and Treatment of Addictive Disorders: A Systematic Review. Segawa, T., Baudry, T., Bourla, A., et al.[2020]

Citations

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Effectiveness of a virtual reality-based cognitive training ... AUDIT is a 10-item screening tool developed to evaluate alcohol consumption, dependence, and harmful consequences, with a clinical threshold indicating ...

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Virtual reality interventions in the assessment and ... Addressing these gaps will be critical for establishing VR as a viable and effective tool in the clinical management of AUD. Abbreviations. RCT.