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

Trial Summary

What is the purpose of this trial?

The relapsing nature of opioid use disorder is a major obstacle to successful treatment. About 90% of those entering treatment will relapse within one year. To improve treatment outcome, new interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate brain connectivity.

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 data supports the effectiveness of the treatment tDCS for opioid addiction?

Research shows that transcranial direct current stimulation (tDCS) can help reduce cravings in people with opioid addiction and other drug dependencies. Studies have found that tDCS applied to specific brain areas can decrease cravings and withdrawal symptoms, making it a promising tool for addiction treatment. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions across various populations, including potentially vulnerable groups like children and the elderly. ^{1 2 3 6 7}

How is the treatment tDCS different from other treatments for opioid addiction?

Transcranial Direct Current Stimulation (tDCS) is unique because it uses a mild electrical current to stimulate specific areas of the brain, which can help reduce cravings and withdrawal symptoms in opioid addiction. Unlike traditional medications, tDCS is non-invasive and targets brain function directly, potentially offering a new way to support recovery. ^{1 2 3 4 8}

Research Team

Kelvin Lim, MD

Principal Investigator

University of Minnesota

Jazmin Y Camchong, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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]

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]

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) 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) 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 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]

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]

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. 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]

2. England pubmed.ncbi.nlm.nih.gov

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

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

A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. [2022]

4. Iran 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. [2022]

5. Iran pubmed.ncbi.nlm.nih.gov

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

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

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

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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