tDCS + TUS for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Ciro R Estebanez, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Case Western Reserve University

Must be taking: Methadone

Must not be taking: Antiepileptics

Disqualifiers: Pregnancy, Illegal stimulant use, Neurological disorders, Severe depression, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have recently started on antiepileptic drugs, you may not be eligible to participate.

What data supports the effectiveness of this treatment for opioid use disorder?

Research shows that transcranial direct current stimulation (tDCS) can reduce cravings for opioids and other substances by altering brain activity. Studies have found that tDCS is effective in reducing drug cravings, which is a major challenge in treating addiction. ^{1 2 3 4 5}

Is tDCS safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans, with studies reporting no significant side effects in participants, including those with substance use disorders. ^{1 2 6 7 8}

How is the tDCS + TUS treatment for opioid use disorder different from other treatments?

The tDCS + TUS treatment is unique because it uses non-invasive brain stimulation techniques to modulate brain activity, potentially reducing cravings and withdrawal symptoms in opioid use disorder. Unlike traditional drug treatments, this approach directly targets brain regions associated with addiction through electrical currents, offering a novel way to address substance use disorders. ^{1 2 6 7 9}

Research Team

Ciro R Estebanez, MD, PhD

Principal Investigator

University Hospitals Cleveland Medical Center/ Case Western Reserve University

Eligibility Criteria

This trial is for adults aged 18-85 with opioid use disorder (OUD) and chronic pain, who have been diagnosed according to DSM-5 criteria. Participants must consent to the study, live locally without relocation plans, and can't be on high doses of methadone. Excluded are pregnant individuals, those with a history of illegal stimulant use or certain neurological disorders, recent brain surgery patients, or those on new antiepileptic drugs.

Inclusion Criteria

I have severe depression based on standard tests.

I am between 18 and 85 years old.

I currently have cancer.

Exclusion Criteria

I have had fainting spells that doctors couldn't explain.

I have not consumed poppy seeds or herbal teas that could affect drug tests.

The subject is pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain

6 weeks

Weekly visits for stimulation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Optimization of NIBS for Treatment of Addiction (Non-invasive Brain Stimulation)

Trial Overview The study tests if transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) helps treat addiction in people with OUD and chronic pain. It compares active stimulation's effects on drug use reduction and psychosocial improvement against sham (fake) treatments.

Participant Groups

Group I: Active (tDCS) + Active TUS Active Control 1 Intervention

Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)

Group II: Sham (tDCS) + Sham TUS Placebo Group 1 Intervention

Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Eric W. Kaler

Case Western Reserve University

Chief Executive Officer since 2021

PhD in Chemical Engineering from the University of Minnesota

Stanton L. Gerson

Case Western Reserve University

Chief Medical Officer since 2020

MD from Harvard Medical School

Highland Instruments, Inc.

Industry Sponsor

Trials

11

Recruited

650+

Findings from Research

In a pilot study involving 28 patients with opioid use disorder on buprenorphine-naloxone, adjunctive high-definition transcranial direct current stimulation (HD-tDCS) significantly reduced cravings and withdrawal symptoms compared to a sham treatment.

Despite the reduction in cravings and withdrawal, there were no significant changes in the levels of glutamate-glutamine and GABA in the left dorsolateral prefrontal cortex, suggesting that the mechanism of action for HD-tDCS may not directly involve these neurotransmitters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive High-Definition Transcranial Direct Current Stimulation in Brain Glutamate-Glutamine and γ-Aminobutyric Acid, Withdrawal and Craving During Early Abstinence Among Patients With Opioid Use Disorder on Buprenorphine-Naloxone: A Proton Magnetic Resonance Spectroscopy-Based Pilot Study. Kumar, AS., Khanra, S., Goyal, N., et al.[2023]

In a study involving 30 patients with heroin dependency, transcranial direct current stimulation (tDCS) effectively reduced the objective measure of cigarette smoking, as indicated by lower expired CO concentrations after 5 days of treatment.

Both the active tDCS and sham control groups reported a decrease in the number of cigarettes smoked, but there was no significant difference in craving levels between the two groups, suggesting that while tDCS may help reduce smoking behavior, it does not significantly impact the desire to smoke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) may reduce the expired CO concentration among opioid users who smoke cigarettes: a randomized sham-controlled study. Lin, SH., Chen, PS., Chen, KC., et al.[2022]

Transcranial direct current stimulation (tDCS) applied to the dorsolateral prefrontal cortex (DLPFC) significantly reduced drug cravings in 40 former crystalline-heroin users enrolled in methadone maintenance programs, indicating its potential as a treatment for addiction.

The study demonstrated that both anodal and cathodal tDCS effectively decreased cravings compared to sham stimulation, supporting the efficacy of tDCS in managing cravings across different types of substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Drug Craving in Crystalline-Heroin Users by Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex. Sharifi-Fardshad, M., Mehraban-Eshtehardi, M., Shams-Esfandabad, H., et al.[2022]

Transcranial direct current stimulation (tDCS) has been shown to significantly reduce cravings for substances like opioids, methamphetamine, cocaine, and tobacco, based on a systematic review of 43 randomized trials involving over 2,000 participants.

The most effective tDCS application involved bilateral stimulation with the anodal electrode on the right dorsolateral prefrontal cortex, using current intensities of 1.5 to 2 mA for 20 minutes, indicating a promising noninvasive approach to managing addiction cravings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting cravings in substance addiction with transcranial direct current stimulation: insights from a meta-analysis of sham-controlled trials. Chan, YH., Chang, HM., Lu, ML., et al.[2023]

In a study involving 13 alcoholics, repeated anodal tDCS over the left dorsolateral prefrontal cortex significantly reduced craving and depressive symptoms compared to a sham treatment, indicating its potential efficacy in managing alcohol dependence.

However, there was a concerning trend showing a higher relapse rate in the tDCS group (66.7%) compared to the sham group (14.3%), suggesting that while tDCS may improve mood and reduce cravings, it could also increase the risk of relapse, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral effects of transcranial direct current stimulation (tDCS) induced dorsolateral prefrontal cortex plasticity in alcohol dependence. da Silva, MC., Conti, CL., Klauss, J., et al.[2022]

Transcranial direct current stimulation (tDCS) has been shown to positively impact clinical measures such as craving and abstinence in individuals with substance use disorders, based on a review of 43 studies.

Despite the promising results, there is a lack of uniformity in the treatment protocols used, indicating that optimal parameters for tDCS need to be established to enhance its effectiveness for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation in substance use disorders: an update]. Tobback, H., Deroost, N., Baeken, C., et al.[2023]

References

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

Transcranial direct current stimulation of the frontal-parietal-temporal area attenuates cue-induced craving for heroin. [2022]

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

Adjunctive High-Definition Transcranial Direct Current Stimulation in Brain Glutamate-Glutamine and γ-Aminobutyric Acid, Withdrawal and Craving During Early Abstinence Among Patients With Opioid Use Disorder on Buprenorphine-Naloxone: A Proton Magnetic Resonance Spectroscopy-Based Pilot Study. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) may reduce the expired CO concentration among opioid users who smoke cigarettes: a randomized sham-controlled study. [2022]

4. Iran pubmed.ncbi.nlm.nih.gov

Modulation of Drug Craving in Crystalline-Heroin Users by Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Targeting cravings in substance addiction with transcranial direct current stimulation: insights from a meta-analysis of sham-controlled trials. [2023]

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

Transcranial direct current stimulation to modulate fMRI drug cue reactivity in methamphetamine users: A randomized clinical trial. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Behavioral effects of transcranial direct current stimulation (tDCS) induced dorsolateral prefrontal cortex plasticity in alcohol dependence. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation in substance use disorders: an update]. [2023]