Auricular Neurostimulation for PTSD and Opioid Use Disorder

Overseen By Irene Ewing, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Must be taking: Buprenorphine

Must not be taking: Sertraline, Paroxetine, Venlafaxine, others

Disqualifiers: Inpatient SUD care, Uncontrolled psychiatric condition, Epileptic seizure, Neurological disorder, others

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

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device, the Sparrow Ascent, to determine if it helps individuals with both PTSD and opioid use disorder adhere to their buprenorphine treatment. The study aims to assess whether the device is easy, comfortable, and acceptable to use while effectively supporting this treatment. Participants will be divided into two groups: one using the active device (Sparrow Ascent tAN, which stands for Transcutaneous Auricular Neurostimulation) and the other using a less active version (Sparrow Ascent Active Sham) to compare results. It suits those with PTSD who are starting or restarting buprenorphine therapy for opioid use disorder and are not currently receiving inpatient care or certain therapies for PTSD. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for PTSD and opioid use disorder.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be stable on medications that affect PTSD for at least four weeks before joining. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Sparrow Ascent device is safe for use in individuals with PTSD and opioid use disorder?

Research has shown that transcutaneous auricular neurostimulation (tAN), as used by the Sparrow Ascent device, is generally safe and well-tolerated. Studies have found that tAN can significantly reduce discomfort during opioid withdrawal. For example, one study reported an average decrease of 7.0 points on a withdrawal symptom scale.

The FDA has cleared the device, indicating it meets safety standards for its intended use. This clearance supports its safety profile. Additionally, another study found that tAN effectively manages withdrawal symptoms without the need for opioids.

Overall, existing evidence suggests that tAN with the Sparrow Ascent device has a good safety record, particularly for those experiencing opioid withdrawal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the auricular neurostimulation techniques being tested for PTSD and opioid use disorder because they offer a new approach by targeting the auricular branch of the vagus nerve. Unlike typical treatments for these conditions, which often involve medications like SSRIs or methadone that come with significant side effects, this treatment uses a non-invasive wearable device called the Sparrow Ascent. It delivers transcutaneous auricular neurostimulation (tAN), potentially offering relief without the need for drugs. The device also includes an active sham version that provides minimal stimulation, which helps researchers understand the true effectiveness of the full treatment. This innovative method could offer a promising alternative for individuals seeking non-pharmacological treatment options.

What evidence suggests that the Sparrow Ascent device is effective for PTSD and opioid use disorder?

Research has shown that transcutaneous auricular neurostimulation (tAN) can help manage opioid withdrawal symptoms. One study found that tAN significantly reduced these symptoms, with an average drop of 7 points on a standard withdrawal scale. This non-invasive method, approved by the FDA, addresses all withdrawal symptoms. Additionally, tAN may help with PTSD symptoms, making it useful for individuals facing both challenges. In this trial, participants will receive either the active tAN treatment or an active sham version. These findings suggest that tAN could support individuals in continuing their buprenorphine treatment by easing withdrawal and PTSD symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Joel Sprunger, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD), who are starting or transitioning to buprenorphine therapy. Participants must meet the DSM-5 criteria for moderate to severe OUD and PTSD, understand English, consent to the study, and allow access to their medical records.

Inclusion Criteria

I have a moderate to severe opioid addiction and am starting or switching to buprenorphine.

I am seeking buprenorphine for opioid addiction and can start the study within a week of beginning treatment.

I have been diagnosed with PTSD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete a baseline assessment capturing demographics, substance use, treatment history, and other relevant measures before randomization.

1 week

1 visit (in-person)

Treatment

Participants are randomized to active tAN or sham condition and use the Sparrow Ascent device for 12 weeks with weekly research visits to monitor substance use, craving, and PTSD symptoms.

12 weeks

12 visits (in-person)

Post-treatment Assessment

Participants complete a post-active treatment assessment similar to the baseline assessment to evaluate changes.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for buprenorphine treatment retention and other outcomes at three and six months post-randomization.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Sparrow Ascent Active Sham
• Sparrow Ascent tAN

Trial Overview The study tests transcutaneous auricular neurostimulation (tAN) using Sparrow Ascent device's impact on maintaining buprenorphine treatment in people with OUD and PTSD. It checks if tAN aids in therapy adherence over three months, its acceptability, comfort level, ease of use alongside buprenorphine treatment, and whether participants stick to recommended usage.

How Is the Trial Designed?

Group I: Active tAN Experimental Treatment 1 Intervention

Participants receive active tAN with the Sparrow Ascent device from Spark Biomedical (Dallas, TX).

Group II: Active Sham Placebo Group 1 Intervention

Participants receive the active sham version of the Sparrow Ascent device that limits stimulation to trigeminal innervation only and at a charge that is approximately 1000x lower than the active tAN condition.

Sparrow Ascent Active Sham is already approved in United States for the following indications:

Approved in United States as Sparrow Ascent for:

• Relief of opioid withdrawal symptoms

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Spark Biomedical, Inc.

Industry Sponsor

Trials

14

Recruited

560+

Published Research Related to This Trial

Auricular acupuncture has been used since the 1970s to help manage acute drug withdrawal symptoms, with over 250 programs established worldwide based on the Lincoln Hospital protocol.

Research suggests that acupuncture can effectively support clients during withdrawal and may serve as a valuable complement to traditional substance abuse treatments, particularly for resistant clients and pregnant or postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture: new perspectives in chemical dependency treatment. Brumbaugh, AG.[2019]

Transcutaneous auricular neurostimulation (tAN) significantly reduced opioid withdrawal symptoms, with a mean decrease of 7.0 points on the Clinical Opiate Withdrawal Scale (COWS) after 60 minutes of treatment, indicating a 45.9% reduction in symptoms.

The study demonstrated that tAN is a safe and effective non-opioid treatment for managing opioid withdrawal syndrome, achieving up to a 74.7% reduction in COWS scores over a 5-day period, supporting its FDA clearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Tirado, CF., Washburn, SN., Covalin, A., et al.[2022]

Seventeen active duty veterans with PTSD reported significant improvements in symptoms after a 3-week regimen of auricular acupuncture, highlighting its potential as a nonpharmacologic treatment option.

The veterans experienced benefits such as better sleep quality, increased relaxation, and decreased pain, indicating a positive reception and perceived effectiveness of auricular acupuncture for managing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Self-Reported Benefits of Auricular Acupuncture Among Veterans With Posttraumatic Stress Disorder. King, CH., Moore, LC., Spence, CD.[2017]

In a pilot study involving 48 inpatients undergoing opioid detoxification, those receiving active transcutaneous electric acupoint stimulation (TEAS) showed significantly lower rates of drug use (35% vs. 77%) compared to those receiving sham treatment by two weeks post-discharge.

Participants in the active TEAS group also reported greater improvements in pain interference and physical health, suggesting that TEAS is a feasible and effective adjunctive treatment for enhancing recovery during opioid detoxification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of transcutaneous electric acupoint stimulation as adjunctive treatment for opioid detoxification. Meade, CS., Lukas, SE., McDonald, LJ., et al.[2022]

In a study involving 280 adults with substance abuse issues, both auricular acupuncture (using NADA and local protocols) and relaxation techniques led to significant improvements in anxiety and insomnia, but there were no significant differences in effectiveness between the groups.

The study found that neither type of acupuncture was more effective than relaxation in addressing anxiety, sleep issues, or reducing drug use, indicating that acupuncture may not provide additional benefits for these problems in patients with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for substance use: a randomized controlled trial of effects on anxiety, sleep, drug use and use of addiction treatment services. Ahlberg, R., Skårberg, K., Brus, O., et al.[2018]

Auricular acupuncture significantly improved treatment compliance and acceptance of discharge recommendations in patients with comorbid substance abuse issues, with 75% compliance in the treatment group compared to only 20% in the control group.

The treatment group also showed a much lower rate of noncompliance or discharge against medical advice (2% vs. 40%) and a higher continuation in follow-up treatment (58% vs. 26%), indicating that auricular acupuncture is a safe and effective intervention for enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is auricular acupuncture beneficial in the inpatient treatment of substance-abusing patients? A pilot study. Gurevich, MI., Duckworth, D., Imhof, JE., et al.[2019]

Auricular acupuncture for smoking cessation was found to be effective, with an odds ratio of 2.24 indicating a significant improvement compared to control interventions in 10 studies, including those of high validity.

However, the effectiveness did not significantly differ between 'correct' and 'incorrect' acupuncture points, suggesting that the location of the points may not be as important as previously thought, challenging the traditional somatotopic model of auricular acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of auricular acupuncture on smoking cessation may not depend on the point chosen--an exploratory meta-analysis. White, A., Moody, R.[2019]

Auricular acupuncture and extended auricular therapy can effectively help with pain and anxiety, but using embedded needles poses significant safety risks, including infections and chondritis, as highlighted by 19 adverse event case reports and multiple safety reviews.

Extended auricular therapy using non-invasive methods, like applying natural seeds, offers similar clinical benefits without the risks associated with embedded needles, suggesting a need for further research to determine the necessity of needle use in auricular treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. Nielsen, A., Gereau, S., Tick, H.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05053503

Study Details | NCT05053503 | Delivering Transcutaneous ... The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385243/

Delivering transcutaneous auricular neurostimulation (tAN) to ... Results demonstrate tAN is a safe and effective non-opioid approach for reducing symptoms of OWS. This study supported an FDA clearance.

3. sparkbiomedical.com sparkbiomedical.com/healthcare-providers/neurological-health

A Better Way Forward in Opioid Withdrawal Management Sparrow Ascent changes the way opioid withdrawal is managed, offering a non-invasive, FDA-cleared solution that directly targets all withdrawal symptoms.

4. withpower.com withpower.com/trial/phase-opioid-related-disorders-2024-e694c

Auricular Neurostimulation for PTSD and Opioid Use ... Transcutaneous auricular neurostimulation (tAN) significantly reduced opioid withdrawal symptoms, with a mean decrease of 7.0 points on the Clinical Opiate ...

5. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/10936531

RePORT RePORTER - National Institutes of Health (NIH) | Transcutaneous auricular neurostimulation (tAN) of the vagus nerve has shown promise for alleviating symptoms of PTSD and opioid withdrawal symptoms (OWS) but ...

6. reporter.nih.gov reporter.nih.gov/search/kEbGvn8JzEiMLF35wrEWgw/project-details/10936531

Improving Buprenorphine Retention with Transcutaneous ... Our phased project will first examine how helpful patients with PTSD and OUD find a device that administers therapeutic electrical stimulation to their vagus ...

7. bioelecmed.biomedcentral.com bioelecmed.biomedcentral.com/articles/10.1186/s42234-022-00095-x

Delivering transcutaneous auricular neurostimulation (tAN ... Results demonstrate tAN is a safe and effective non-opioid approach for reducing symptoms of OWS. This study supported an FDA clearance.