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

Trial Summary

What is the purpose of this trial?

The goal of this research study supported by the HEAL Initiative (https://heal.nih.gov) is to investigate the effects transcutaneous auricular neurostimulation (tAN), as delivered through the Sparrow Ascent device, on helping people with co-occurring posttraumatic stress disorder (PTSD) and opioid use disorder (OUD) start and continue buprenorphine treatment. The main questions it aims to answer are: * Does the tAN help participants with OUD and PTSD remain in buprenorphine therapy for three months after starting use of the device (i.e., randomization to treatment condition)? * Do participants find the Sparrow Ascent device to be acceptable and use it? * Do participants find the Sparrow Ascent device to be tolerable and comfortable to use? * Do participants find the Sparrow Ascent device to be easy to use with their buprenorphine therapy? * Do participants follow the minimum recommended dose schedule for the Sparrow Ascent device most of the time? Participants will complete a baseline assessment to make sure that they are eligible to participate in the study. The assessment captures information about demographics, substance use and treatment history, opioid withdrawal symptoms and craving, difficult life experiences and PTSD symptoms, mental health and treatment history, quality of life, and recovery resources. After the assessment is complete and the participant has been inducted on buprenorphine as part of standard care, they are randomized to one of two treatment conditions: active tAN and placebo. Participants are trained on how to use the device and return for 12 weekly research visits to check on recent substance use and craving, PTSD symptoms, and their experience using the device. After 12 weeks of using the device, participants will complete a post-active treatment assessment that is nearly identical to the baseline assessment to see if there have been changes in these areas. Researchers will access the medical record to determine whether there is a current prescription for buprenorphine at three months and six months after randomization.

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 data supports the effectiveness of the treatment Sparrow Ascent Active Sham, Sparrow Ascent, Transcutaneous Auricular Neurostimulation (tAN), Sparrow Ascent tAN, Sparrow Ascent, Transcutaneous Auricular Neurostimulation (tAN) for PTSD and Opioid Use Disorder?

Research shows that transcutaneous auricular neurostimulation (tAN) is effective in managing symptoms of opioid withdrawal, suggesting it may help with opioid use disorder. Additionally, auricular acupuncture, a similar treatment, has been used successfully for drug withdrawal and dependency, indicating potential benefits for related conditions. ^{1 2 3 4 5}

Is auricular neurostimulation safe for humans?

Research on auricular acupuncture, a similar treatment, shows it is generally safe with negligible side effects. This suggests that auricular neurostimulation may also be safe for humans. ^{1 2 3 5 6}

How is the Sparrow Ascent tAN treatment different from other treatments for PTSD and opioid use disorder?

Sparrow Ascent tAN is unique because it uses transcutaneous auricular neurostimulation (tAN), which involves stimulating nerves in the ear to help manage symptoms of PTSD and opioid withdrawal, offering a non-drug alternative to traditional pharmacological treatments. ^{1 3 5 7 8}

Research Team

Joel Sprunger, PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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 between 18 and 65 years old.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. [2022]

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

A randomized trial of transcutaneous electric acupoint stimulation as adjunctive treatment for opioid detoxification. [2022]

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

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

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

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. [2021]

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

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

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

Is auricular acupuncture beneficial in the inpatient treatment of substance-abusing patients? A pilot study. [2019]

7. England 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. [2018]

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

Exploring Self-Reported Benefits of Auricular Acupuncture Among Veterans With Posttraumatic Stress Disorder. [2017]