Ultrasound Therapy for Opioid Use Disorder

Overseen By Jennifer Marton

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ali Rezai

Disqualifiers: Neurological disorders, Stroke, Schizophrenia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

34 Participants Needed

Trial Summary

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 study team to get a clear answer.

What data supports the effectiveness of the treatment LIFU (Low-Intensity Focused Ultrasound) for opioid use disorder?

Research on various neuromodulation techniques, including low-intensity focused ultrasound, shows promise in reducing substance cravings and improving treatment outcomes for substance use disorders. These techniques have been effective in treating other neurological and psychiatric conditions, suggesting potential benefits for opioid use disorder as well. ^{1 2 3 4 5}

How is LIFU treatment different from other treatments for opioid use disorder?

LIFU (Low-Intensity Focused Ultrasound) is unique because it is a noninvasive brain stimulation technique that uses sound waves to target specific brain areas, potentially offering a new way to help manage opioid use disorder without the need for medication. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.

Research Team

Ali Rezai

Principal Investigator

Executive Director WVU Rockefeller Neuroscience Institute

Eligibility Criteria

This trial is for adults aged 22-60 with severe opioid use disorder (OUD) that's lasted at least two years. Women who can have children must test negative for pregnancy and agree to use birth control. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception

I am between 22 and 60 years old.

Fulfill current DSM-5 diagnostic criteria for severe OUD with at least a 2-year history

Exclusion Criteria

Unable to speak, read and understand English

Subject is considered to be a poor surgical or study candidate

I have a significant neurological condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low Intensity Focused Ultrasound (LIFU) or sham treatment targeting the NAc and VC

Duration not specified

Follow-up

Participants are monitored for changes in opioid use and treatment emergent adverse events

90 days

Treatment Details

Interventions

• LIFU

Trial Overview The study tests Low Intensity Focused Ultrasound (LIFU) on the brain areas NAc and VC, comparing it with a sham (fake treatment) in people whose OUD hasn't improved with standard treatments. Participants are chosen randomly to receive either LIFU or the sham.

Participant Groups

Group I: LIFU Treatment Experimental Treatment 1 Intervention

Group II: Sham treatment Placebo Group 1 Intervention

LIFU is already approved in United States for the following indications:

Approved in United States as Focused Ultrasound for:

• Essential Tremor
• Parkinson’s Disease

Who Is Running the Clinical Trial?

Ali Rezai

Lead Sponsor

Trials

6

Recruited

90+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study of 164 rehabilitating heroin users treated with transcutaneous electrical acupoint stimulation (TEAS) for at least 3 months, 32.3% remained drug-free after 12 months, which is significantly higher than the typical relapse rate of less than 5% without further intervention.

The use of the Han's acupoint nerve stimulator (HANS) appears to effectively reduce relapse rates among detoxified heroin users, indicating its potential as a supportive treatment in addiction recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prospective study of Han's acupoint nerve stimulator for preventing relapse of detoxified heroin addicts]. Fang, J., Ma, D., Zhong, J., et al.[2019]

Acupuncture has shown potential benefits in treating opioid use disorder (OUD), particularly in reducing cravings, insomnia, and depression, based on a systematic review of nine studies with 1063 participants.

Electroacupuncture (EA) was found to significantly alleviate opioid cravings and depression symptoms, while transcutaneous acupoint electrical stimulation (TEAS) effectively improved insomnia and anxiety symptoms compared to sham treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Acupuncture for Treating Opioid Use Disorder in Adults: A Systematic Review and Meta-Analysis. Chen, Z., Wang, Y., Wang, R., et al.[2022]

Naltrexone, used as an adjuvant therapy for young heroin addicts, showed minimal side effects and was positively received by most participants, with 11 out of 16 patients rating it as somewhat or very positive after a six-month trial.

At a four-year follow-up, 6 out of 16 patients were rehabilitated without illegal substance use, suggesting that while naltrexone can enhance treatment, its long-term effectiveness may be limited and should be combined with other therapies like methadone maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of naltrexone in the treatment of young drug addicts]. Waal, H., Aamodt, Ø., Olsen, H.[2013]

A randomized controlled trial with 50 participants showed that combining electroacupuncture with auricular point pressing significantly improved mental health scores compared to auricular point pressing alone, indicating enhanced quality of life for individuals undergoing methadone maintenance treatment.

The combined therapy also led to a greater reduction in methadone dosage, suggesting that this treatment approach may help in managing heroin use disorder more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Electroacupuncture Combined with Auricular Point Pressing in Improving Mental Well-Being among Individuals with Heroin Use Disorder: A Randomized Controlled Crossover Trial and Pilot Study. Yu, KC., Wei, HT., Chang, SC., et al.[2022]

Neuromodulation techniques, particularly transcranial magnetic stimulation, show promise in reducing substance cravings and improving treatment outcomes for individuals with substance use disorder, based on a review of various studies.

Several forms of neuromodulation, both invasive and non-invasive, are being explored as potential non-pharmacological treatments for substance use disorder, highlighting the need for further research to establish their efficacy and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation, deep brain stimulation, and other forms of neuromodulation for substance use disorders: Review of modalities and implications for treatment. Mahoney, JJ., Hanlon, CA., Marshalek, PJ., et al.[2021]

Noninvasive brain stimulation (NIBS) shows potential as a novel treatment strategy for opioid use disorder (OUD), but current research is limited, with only five studies involving a total of 150 participants identified in a systematic review.

The studies utilized various NIBS techniques, including TMS and tDCS, to target issues like cue-induced craving and withdrawal symptoms, indicating that while promising, more extensive research is needed to fully understand the efficacy and mechanisms of NIBS in treating OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Noninvasive Brain Stimulation for Opioid Use Disorder. Ward, HB., Mosquera, MJ., Suzuki, J., et al.[2022]

Implementing quality improvement processes, including motivational interviewing training and reduced initial treatment requirements, significantly improved the 6-month retention rate for adolescents and young adults in a medication-assisted treatment clinic for opioid use disorders.

Additional support measures like transportation assistance and incentive programs also led to a notable increase in the rate of patients returning for their second visit, highlighting the importance of accessibility and motivation in treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifaceted Quality Improvement Initiative Improves Retention in Treatment for Youth with Opioid Use Disorder. Cottrill, CB., Lemle, S., Matson, SC., et al.[2022]

In a retrospective overview of 42 patients with Opioid Use Disorders, 62% showed significant positive responses to unilateral transcranial photobiomodulation (UtPBM) as an adjunct therapy, indicating its potential efficacy in enhancing treatment outcomes.

The treatment was reported to be safe, with no significant side effects observed, aside from temporary anxiety in two patients that resolved with psychotherapy, suggesting that UtPBM could be a beneficial addition to existing therapies for OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilateral transcranial photobiomodulation for opioid addiction in a clinical practice: A clinical overview and case series. Schiffer, F.[2021]

Vaccines for opioid use disorder (OUD) are being explored as a novel treatment option that could complement existing medications, addressing barriers to treatment initiation and retention.

Promising results from preclinical trials suggest that opioid vaccines may provide protection against overdose and improve treatment outcomes, indicating a potential shift in how OUD is managed in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapeutic strategies for treating opioid use disorder and overdose. Luba, R., Martinez, S., Jones, J., et al.[2023]

A pilot study involving three patients with long-standing opioid dependency showed that treatment with a high-intensity cold laser device allowed them to discontinue all opioid medications after 8-12 sessions over 3-4 weeks.

At follow-up 1-2 months later, these patients reported effective pain control using only over-the-counter non-opioid analgesics, suggesting that this non-pharmacologic approach may be a promising alternative for managing chronic pain and reducing opioid dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel treatment for chronic opioid use after surgery. White, PF., Elvir-Lazo, OL., Hernandez, H.[2018]

References

1. China pubmed.ncbi.nlm.nih.gov

[Prospective study of Han's acupoint nerve stimulator for preventing relapse of detoxified heroin addicts]. [2019]

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

Efficacy of Acupuncture for Treating Opioid Use Disorder in Adults: A Systematic Review and Meta-Analysis. [2022]

3. Norway pubmed.ncbi.nlm.nih.gov

[Use of naltrexone in the treatment of young drug addicts]. [2013]

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

Efficacy of Electroacupuncture Combined with Auricular Point Pressing in Improving Mental Well-Being among Individuals with Heroin Use Disorder: A Randomized Controlled Crossover Trial and Pilot Study. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation, deep brain stimulation, and other forms of neuromodulation for substance use disorders: Review of modalities and implications for treatment. [2021]

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

A Systematic Review of Noninvasive Brain Stimulation for Opioid Use Disorder. [2022]

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

Multifaceted Quality Improvement Initiative Improves Retention in Treatment for Youth with Opioid Use Disorder. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Unilateral transcranial photobiomodulation for opioid addiction in a clinical practice: A clinical overview and case series. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Immunotherapeutic strategies for treating opioid use disorder and overdose. [2023]

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

A novel treatment for chronic opioid use after surgery. [2018]