Ultrasound Therapy for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Ali Rezai

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ali Rezai

Disqualifiers: Neurological disorders, Stroke, Schizophrenia, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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}

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.

Trial 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 (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

WVU Rockefeller Neuroscience Institute Morgantown, WV

Who Is Running the Clinical Trial?

Ali Rezai

Lead Sponsor

Trials

6

Patients Recruited

90+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2658

Patients Recruited

3,409,000+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]

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]