Audio-Visual Stimuli for Opioid Use Disorder

Overseen By Anna Konova, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: OUD treatment medications

Must not be taking: Antidepressants, Ritalin

Disqualifiers: Schizophrenia, Bipolar, Seizures, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how craving affects decision-making in people with opioid use disorder (OUD). The researchers use audio-visual stimuli (therapy involving sound and visual elements) to observe how cravings for opioids or snacks alter willingness to pay for certain items. Participants complete tasks while researchers monitor their brain activity to better understand these interactions. Ideal candidates are individuals treated for opioid use disorder with a history of opioid use for at least 12 months. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance understanding and treatment of OUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are a community control participant, you must not have used central nervous system medications (like antidepressants or Ritalin) in the past 6 weeks.

What prior data suggests that audio-visual stimuli are safe for use in this study?

Research shows that sights and sounds can influence responses to drugs or food. Although limited safety information exists for using these methods to treat opioid use disorder (OUD), their use in similar contexts appears safe. For instance, studies have found that adding audio-visual elements can reduce the need for emergency care, suggesting a positive and manageable experience. While these findings don't directly prove safety, they offer some reassurance. Additionally, these treatments don't involve anything entering the body, generally making them less risky than other medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using audio-visual stimuli for opioid use disorder because this approach taps into the brain's response to visual and auditory cues, which can alter psychological states and cravings. Unlike traditional treatments like medications or behavioral therapy, this method involves exposing individuals to specific stimuli that can either relax them or trigger cravings, observed through fMRI brain scans. This innovative technique could offer new insights into how external stimuli affect decision-making and cravings, potentially leading to more effective and personalized treatment strategies for managing opioid use disorder.

What evidence suggests that this trial's audio-visual stimuli could be effective for opioid use disorder?

Research has shown that sights and sounds can change how people feel and might help reduce cravings. One study on individuals with chronic pain found that those who used these sights and sounds required less medication, such as painkillers and antidepressants. This suggests that these stimuli might help manage cravings by altering mental states. However, other research on addiction found that while using both sights and sounds together is effective, using sounds alone might be even more effective. In this trial, participants will encounter different audio-visual stimuli during separate tasks to assess their impact on cravings and decision-making in individuals with opioid use disorder. Overall, promising evidence suggests that these stimuli can influence cravings and decision-making in this population. ^{1 5 6 7 8}

Who Is on the Research Team?

Anna Konova, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

This trial is for individuals who experience strong cravings, particularly those in treatment for opioid use disorder (OUD), as well as people from the general population. Participants will engage in decision-making tasks related to their cravings, whether it's for drugs or specific snacks.

Inclusion Criteria

Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures

Minimum of 6th grade reading level

I have been diagnosed with opioid use disorder, am on medication for it, and have used opioids for over a year.

Exclusion Criteria

Severe medical conditions requiring hospitalization or that, in the opinion of the study staff could compromise study participation

Unable to speak or read English

Active psychosis or mania

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete decision-making tasks during fMRI to measure willingness-to-pay for consumer items and snack foods, with interleaved psychological/behavioral interventions.

6-8 weeks

Multiple visits for fMRI sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Audio-visual stimuli

Trial Overview The study tests how craving affects decision-making and value assignment using cognitive tasks with audio-visual stimuli. It involves measuring brain activity while participants decide how much they're willing to pay for items associated with their cravings.

How Is the Trial Designed?

Group I: Snack Foods Willingness-to-Pay Task Experimental Treatment 2 Interventions

Men and women with OUD receiving medications for OUD treatment and control participants from the community will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for snack food items that vary in their features (savory, sweet, etc.). Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and food craving, via two psychological/behavioral interventions: Audio-visual stimuli (Non-Food) and Audio-visual stimuli (Food).

Group II: Consumer Items Willingness-to-Pay Task Experimental Treatment 2 Interventions

Men and women with OUD receiving medications for OUD treatment will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for everyday consumer items that have associations with drug use or not. Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and drug craving, via two psychological/behavioral interventions: Audio-visual stimuli (Neutral-Relaxing) and Audio-visual stimuli (Drug).

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The TAAB study is a pilot randomized controlled trial designed to evaluate the effectiveness of video directly observed therapy (DOT) via a smartphone app on improving adherence to buprenorphine treatment for opioid use disorder, involving 13 weekly in-person visits and follow-ups at 12 and 24 weeks.

The primary outcome of the study is the percentage of weekly urine tests negative for opioids over 12 weeks, which will help assess whether video DOT can enhance treatment success by increasing accountability and structure for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video directly observed therapy intervention using a mobile health application among opioid use disorder patients receiving office-based buprenorphine treatment: protocol for a pilot randomized controlled trial. Schramm, ZA., Leroux, BG., Radick, AC., et al.[2022]

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]

This meta-analysis of 10 studies involving 296 individuals with opioid use disorder (OUD) and 187 healthy controls identified significant hyperactivation in brain regions associated with craving, particularly in the mesocorticolimbic, nigrostriatal, and corticocerebellar systems.

The findings suggest that pharmacological treatments like buprenorphine/naloxone and cognitive-behavioral therapies, such as cue-exposure combined with heart rate variability biofeedback, could be effective interventions for managing cravings in OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional neuroanatomy of craving in heroin use disorder: voxel-based meta-analysis of functional magnetic resonance imaging (fMRI) drug cue reactivity studies. Pollard, AA., Hauson, AO., Lackey, NS., et al.[2023]

Individuals with opioid-use disorder (OUD) show increased brain activation in response to heroin cues, which is influenced by medication-assisted treatments and can predict treatment outcomes.

Despite these insights, there is a lack of research on the neural mechanisms of OUD and its treatments, highlighting the need for more studies, especially focusing on prescription opioid users and sex differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can neuroimaging help combat the opioid epidemic? A systematic review of clinical and pharmacological challenge fMRI studies with recommendations for future research. Moningka, H., Lichenstein, S., Worhunsky, PD., et al.[2023]

Veterans are at a higher risk of accidental overdose from opioids, being twice as likely to die from such incidents compared to the general population, which underscores the urgent need for effective treatment strategies.

A brief, one-session Computerized Anxiety Sensitivity Treatment (CAST) was well-received by veterans with opioid use disorder, showing promising reductions in anxiety and substance use, suggesting it could be a beneficial intervention in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized anxiety sensitivity intervention for opioid use disorders: A pilot investigation among veterans. Raines, AM., Allan, NP., McGrew, SJ., et al.[2021]

In a study of 785 adolescents and young adults with opioid use disorder, those receiving motivational enhancement therapy combined with cognitive-behavioral therapy (MET/CBT) or CBT alone had better outcomes than those receiving the adolescent community reinforcement approach (A-CRA).

The effectiveness of treatments varied by age and sex, with male adolescents benefiting more from MET/CBT or CBT alone, while female young adults showed lower rates of opioid use with treatment as usual (TAU) compared to A-CRA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the opioid epidemic with behavioral interventions for adolescents and young adults: A quasi-experimental design. Davis, JP., Prindle, JJ., Eddie, D., et al.[2019]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

In a pilot study involving 78 adults with opioid use disorder, the use of video directly-observed therapy (DOT) for buprenorphine did not lead to better outcomes in terms of negative urine drug tests compared to standard treatment, with 50% negative tests in the video DOT group versus 64% in the treatment-as-usual group.

Engagement in treatment at week 12 was also lower in the video DOT group (69%) compared to the standard treatment group (82%), indicating that the video monitoring approach may not be more effective than traditional methods for supporting patients in their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video directly observed therapy for patients receiving office-based buprenorphine - A pilot randomized controlled trial. Tsui, JI., Leroux, BG., Radick, AC., et al.[2022]

Individuals with heroin use disorder (iHUD) showed increased brain activity in areas associated with craving, such as the orbitofrontal cortex, while watching drug-themed movies, indicating a strong connection between drug cues and motivational responses.

After 15 weeks of inpatient treatment, the reduced brain response to drug cues in the orbitofrontal cortex correlated with decreased cravings, suggesting that this neural response could serve as a marker for recovery progress in individuals with iHUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic drug cue reactivity in heroin use disorder: orbitofrontal synchronization as a marker of craving and recovery. Kronberg, G., Ceceli, AO., Huang, Y., et al.[2023]

Participants with opioid use disorder (OUD) on opioid agonist treatment (OAT) showed heightened positive responses to drug-related images but blunted responses to pleasant stimuli compared to a control group, indicating altered emotional processing.

Increased recent illicit opioid use was linked to reduced attention to pleasant images, suggesting that interventions should focus on enhancing attention to positive stimuli, which may be crucial for improving treatment outcomes in OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Startle-elicited Event-Related Potentials to Affective Stimuli are Associated with Recent Illicit Opioid use among Patients Receiving Opioid Agonist Treatment. Garfield, JB., Cheetham, A., Allen, NB., et al.[2022]

In a study involving 16 male heroin addicts and 12 matched controls, opiate users showed significantly greater attentional processing (measured by P300 responses) to drug-related images compared to neutral and affective images, indicating heightened sensitivity to drug cues.

The level of craving in opiate addicts predicted their attentional response to drug-related stimuli, while they did not show the typical enhanced response to non-drug affective stimuli, suggesting a specific focus on drug cues over other emotional signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological evidence that drug cues have greater salience than other affective stimuli in opiate addiction. Lubman, DI., Allen, NB., Peters, LA., et al.[2022]

Buprenorphine significantly increased both auditory and visual thresholds and reaction times in baboons, indicating its potent effects on sensory processing and response times.

Morphine increased reaction times to certain stimuli but did not affect sensory thresholds, while naloxone showed no consistent effects, suggesting that buprenorphine has a more pronounced impact on sensory functions compared to morphine and naloxone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute opioid administration effects on sensory and motor function in baboons: buprenorphine, morphine, and naloxone. Spear, DJ., Hienz, RD., Brady, JV.[2019]

Current heroin users exhibit heightened emotional responses to unpleasant stimuli and reduced responses to pleasant stimuli compared to healthy individuals, indicating an abnormal emotional experience.

In contrast, both current and abstinent heroin users show greater emotional responses to neutral images, suggesting a potential impact of opioid use on emotional processing and sensitivity to positive reinforcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysregulation of emotional response in current and abstinent heroin users: negative heightening and positive blunting. Aguilar de Arcos, F., Verdejo-García, A., Ceverino, A., et al.[2022]

A study involving 28 individuals with opioid use disorder (OUD) and chronic pain found that a cognitive bias modification (CBM) task significantly reduced attentional bias towards opioid and pain cues, suggesting it may help in managing cravings and pain in OUD treatment.

Participants reported high feasibility and acceptability of the CBM task, attending 83.3% of sessions, indicating that integrating such cognitive tasks into regular medication for OUD could be beneficial for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating cognitive bias modification for pain and opioid cues into medication for opioid use disorder clinical care: Feasibility, acceptability, and preliminary results. MacLean, RR., Heapy, AA., Waters, AJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6710415/

Visual and Auditory Reaction Times of Patients with Opioid ... Results. The results showed longer reaction times in the patients with opioid use disorder. Conclusion. To add improving reaction time approaches in opioid use ...

2. researchgate.net researchgate.net/publication/383113411_Audio-Visual_Stimulation_Therapy_for_Chronic_Neuropathic_Pain_A_Sham-Controlled_Randomized_Clinical_Trial

Audio-Visual Stimulation Therapy for Chronic Neuropathic ... Participants in the Active arm had significant decreases in use of anxiolytic, opiate, antidepressant, and anticonvulsant medications compared ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70164

Effect of EEG neurofeedback therapy on addiction disorders Auditory feedback was the most effective modality, while audio-visual feedback was less effective and visual feedback was the weakest.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528323/

A Systematic Review of Noninvasive Brain Stimulation for ... We conducted a systematic review of studies using noninvasive brain stimulation to affect clinical outcomes related to substance use for adults with opioid use ...

5. psychiatryinvestigation.org psychiatryinvestigation.org/upload/pdf/pi-2019-05-16.pdf

Visual and Auditory Reaction Times of Patients with Opioid ... Results The results showed longer reaction times in the patients with opioid use disorder. Conclusion To add improving reaction time ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11847226/

Association between different modalities of opioid use ... Care through audio only visits was associated with lower rates of ED visits. Care through audiovisual visits was associated with lower rates ...

7. researchgate.net researchgate.net/publication/377497021_Challenging_the_Nuances_of_Pain_Assessment_With_Co-designed_Audio-Visual_Simulations_in_Nursing_Education_A_Descriptive_Study

Challenging the Nuances of Pain Assessment With Co- ... This study developed and evaluated new audiovisual (AV) simulations for nursing students showcasing patient characteristics that may influence pain assessment.

8. beckersbehavioralhealth.com beckersbehavioralhealth.com/behavioral-health-addiction-treatment/from-lab-to-life-how-virtual-reality-and-wearable-sensors-are-transforming-sud-recovery/

From lab to life: How virtual reality and wearable sensors ... The results offer preliminary evidence that recovery cue exposure can help regulate an individual's response to substance stimuli, according to ...