Neuromodulation for Opioid Addiction

Overseen By Jazmin Y Camchong, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Neurological conditions, Severe TBI, Seizures, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called transcranial direct current stimulation (tDCS) to help reduce relapse in people with opioid addiction. tDCS is a safe, non-invasive method to stimulate the brain and may alter brain patterns linked to addiction. Participants will receive either the active tDCS treatment or a sham (placebo) version that mimics the sensation without actual stimulation. The trial seeks individuals who have abstained from opioids for 1-2 weeks and are in a supervised treatment program. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new addiction treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants may have comorbid drug use, suggesting that some medications might be allowed. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for opioid addiction treatment?

Research has shown that transcranial direct current stimulation (tDCS) is generally easy for people to handle. Studies have found this method safe for treating various conditions, including opioid use disorder. A review of several studies found that tDCS can help reduce cravings and prevent relapse, with only a few minor side effects reported.

In one study on heroin use, participants did not report any major negative effects from tDCS. Another study on chronic pain found that tDCS is a simple and safe way to change brain activity. Participants usually feel minor sensations like tingling on the scalp, but serious side effects are rare.

Overall, evidence supports tDCS as a safe option for those considering participation in trials for opioid addiction treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial Direct Current Stimulation (tDCS) for opioid addiction because it offers a non-invasive way to potentially alter brain activity, which is different from typical treatments like medication-assisted therapy using methadone or buprenorphine. Unlike these medications, which work by interacting with opioid receptors to reduce cravings and withdrawal symptoms, tDCS uses a small electrical current applied to the scalp to modulate neural circuits involved in addiction. This method could reduce dependence on drugs and minimize side effects, providing a promising new avenue for treatment.

What evidence suggests that tDCS is effective for opioid addiction?

Research has shown that transcranial direct current stimulation (tDCS) might help reduce cravings and withdrawal symptoms in people with opioid addiction. In this trial, participants will receive either active tDCS or sham tDCS at random. Studies have found that tDCS can slightly lower cravings for opioids and other drugs like methamphetamine and cocaine. This non-invasive method, which does not involve surgery, works by altering brain activity to help manage addiction. Various studies have linked tDCS to a decrease in drug cravings and use, suggesting that it could be a helpful tool for supporting recovery in people with opioid use disorder. ^{5 6 7 8 9}

Who Is on the Research Team?

Kelvin Lim, MD

Principal Investigator

University of Minnesota

Jazmin Y Camchong, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-60 with opioid use disorder (OUD) who have been abstinent for 1-2 weeks and are part of the Lodging Plus Program. They must be able to consent and follow study procedures, with OUD as their primary diagnosis even if they use other drugs. Excluded are those with conditions affecting study participation or tDCS/MRI contraindications like metal implants, seizures, or severe head injuries.

Inclusion Criteria

Ability to provide written consent and comply with study procedures, meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for OUD

You may be using other drugs, but the main reason for your treatment should be an addiction to opioids.

I am 18-60 years old, have not used opioids for 1-2 weeks, and have been diagnosed with opioid use disorder.

Exclusion Criteria

Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine

I have been diagnosed with Wernicke-Korsakoff syndrome.

You have been diagnosed with a psychiatric disorder, such as depression, based on specific criteria outlined in the DSM-V.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo five sessions of tDCS or sham tDCS across five days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI scans and clinical interviews

2 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The trial tests Transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique that may modulate brain connectivity. It aims to reduce relapse in people with OUD by targeting brain biomarkers associated with vulnerability to relapse.

How Is the Trial Designed?

Group I: Experimental: active tDCS Experimental Treatment 1 Intervention

Subjects that are randomly assigned to this arm will undergo 5 sessions of tDCS.

Group II: Sham Comparator: sham tDCS Placebo Group 1 Intervention

Subjects randomly assigned to sham-tDCS will receive very low current stimulation at the beginning and end of the session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. There will be a total of 5 sham tDCS sessions.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

A single session of transcranial direct current stimulation (tDCS) applied to the bilateral frontal-parietal-temporal areas significantly reduced craving scores in 20 long-term heroin addicts, demonstrating its potential efficacy in managing addiction-related cravings.

No side effects were reported from the tDCS treatment, indicating that it is a safe intervention for reducing cue-induced cravings in heroin addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the frontal-parietal-temporal area attenuates cue-induced craving for heroin. Wang, Y., Shen, Y., Cao, X., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) significantly increased Brain-Derived Neurotrophic Factor (BDNF) levels and reduced psychological symptoms such as depression, anxiety, and stress in opioid-addicted patients, based on a study of 30 participants.

Both anodal and cathodal stimulation of the Dorsolateral Prefrontal Cortex (DLPFC) were effective, with the right DLPFC stimulation notably increasing BDNF and decreasing anxiety and craving, while the left DLPFC stimulation effectively reduced depression, anxiety, stress, and craving without affecting BDNF levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Efficacy of Anodal, Cathodal, and Sham Transcranial Direct Current Stimulation on Brain-Derived Neurotrophic Factor and Psychological Symptoms in Opioid-Addicted Patients. Eskandari, Z., Dadashi, M., Mostafavi, H., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

In a clinical trial with 36 male crack-cocaine users, transcranial direct current stimulation (tDCS) significantly reduced craving for crack-cocaine compared to a sham treatment, with effects lasting for 4 weeks after the sessions.

tDCS also led to decreased anxiety and improved quality of life, suggesting that it may enhance prefrontal brain function to help regulate craving behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. Batista, EK., Klauss, J., Fregni, F., 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10262281/

Impact of Transcranial Direct Current Stimulation on Ultra- ... The study's results support the hypothesis that tDCS reduces craving and withdrawal symptoms caused by treating opioid addiction with ultra-rapid opioid ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165178123005711

Targeting cravings in substance addiction with transcranial ... Our meta-analysis indicated that tDCS led to a modest reduction in cravings for opioids, methamphetamine, cocaine, and tobacco but not for alcohol or cannabis.

3. cpn.or.kr cpn.or.kr/journal/view.html?uid=1646&vmd=Full

Effect of Intensified Transcranial Direct-current Stimulation ... According to a review of the results from various studies, tDCS is associated with reductions in craving and other symptoms of drug intoxication [20-22].

4. brieflands.com brieflands.com/journals/ijhrba/articles/94499

International Journal of High Risk Behaviors and Addiction The results of repeated measures ANOVA showed that both sequences had a significant, long-term effect on the reduction of current drug craving and drug-use ...

5. journal.ppcr.org journal.ppcr.org/index.php/ppcrjournal/article/view/86

Transcranial Direct Current Stimulation for Opioid use disorder It has been used to reduce craving in substance use disorder (SUD). tDCS may be used in opioid use disorder to reduce craving and drug use.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11289614/

Effect of Intensified Transcranial Direct-current Stimulation ... This study aimed to analyze the effect of the intensified tDCS targeting bilateral DLPFC on drug craving reduction among individuals with heroin use disorder.

7. sciencedirect.com sciencedirect.com/science/article/pii/S000632232500023X

Exploring a Novel Treatment for Severe Opioid Use Disorder Our results show that in drug abstinent participants, bilateral NAc FUS neuromodulation for severe, primary OUD and co-occurring SUD is safe and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05863494

Transcranial Direct Current Stimulation and Chronic Pain The overarching goal of this project is to apply transcranial direct current stimulation (tDCS) as an alternative to opioids for the reduction in chronic pain.

9. nature.com nature.com/articles/s41386-023-01776-0

A systematic review and meta-analysis of neuromodulation ... Ninety-four studies were identified that examined the effects of rTMS, tDCS, and DBS on substance use outcomes (eg, craving, consumption, and relapse)