Transcranial Direct Current Stimulation for Opioid Use Disorder

Overseen By Clarista Berg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must be taking: Buprenorphine

Disqualifiers: Neurological conditions, Psychotic disorders, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Transcranial Direct Current Stimulation (tDCS) can aid individuals with opioid use disorder (OUD) who are already receiving buprenorphine treatment. The study compares real tDCS sessions to placebo sessions to determine any added benefit in managing OUD. Suitable candidates for this trial include those currently treated with buprenorphine for OUD who plan to continue their treatment program until the study concludes. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for OUD alongside current therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on buprenorphine maintenance treatment to participate.

What prior data suggests that transcranial direct current stimulation is safe for individuals with opioid use disorder?

Research has shown that transcranial direct current stimulation (tDCS) is a promising and low-risk method. Studies have found that tDCS can help reduce cravings for opioids and other substances. It is considered safe, easy to use, and effective for influencing brain activity.

In earlier studies, participants using tDCS reported it was well-tolerated, with most experiencing no serious side effects. Overall, tDCS is a safe option for those wanting to reduce cravings while managing substance use disorders. For those considering joining a trial with tDCS, current research suggests it is generally safe and carries a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Direct Current Stimulation (tDCS) is unique because it offers a non-invasive way to potentially treat opioid use disorder. Unlike traditional treatments like medication-assisted therapy, which uses drugs like methadone or buprenorphine, tDCS involves applying a small electrical current to the scalp to modulate brain activity. Researchers are excited about this approach because it targets brain areas involved in addiction, offering a new mechanism that could complement existing therapies. This method is promising as it might reduce cravings and withdrawal symptoms without the side effects associated with medication.

What evidence suggests that transcranial direct current stimulation is effective for opioid use disorder?

Research has shown that transcranial direct current stimulation (tDCS), which participants in this trial may receive, can slightly reduce cravings for opioids. A study that combined results from multiple research projects found that tDCS helped lower cravings for drugs like opioids, methamphetamine, and cocaine. It also appears to reduce drug use in people with addiction issues. Additionally, tDCS might improve cognitive skills such as decision-making and planning, which can benefit those struggling with addiction. These findings suggest that tDCS could be a useful tool in managing opioid use disorder. ^{2 3 4 5 6}

Who Is on the Research Team?

Jazmin Camchong, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults with Opioid Use Disorder (OUD) who are currently receiving buprenorphine treatment and can follow study procedures. Participants must not have a primary substance use disorder other than opioids, be pregnant, or exhibit disrespectful behavior. They also cannot have any conditions that contraindicate tDCS or MRI.

Inclusion Criteria

Ability to provide consent and comply with study procedures

Meet Diagnostic and Statistical Manual of Mental Disorders criteria for OUD

Intention to remain in the addiction treatment program until intervention completion

Exclusion Criteria

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

Court mandated treatment

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neuromodulation intervention using the Soterix Mini-CT Remote tDCS device while under buprenorphine maintenance treatment

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study examines the effectiveness of adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to cognitive training in individuals undergoing buprenorphine maintenance for OUD. Some participants will receive sham stimulation as a control comparison.

How Is the Trial Designed?

Group I: tDCS Active Control 1 Intervention

All intervention sessions will use the Soterix Mini-CT Remote tDCS device

Group II: Sham Electrodes Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528323/

A Systematic Review of Noninvasive Brain Stimulation for ... We conducted a systematic review of studies using noninvasive brain stimulation to affect clinical outcomes related to substance use for adults with opioid use ...

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. 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. We ...

4. 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.

5. ejnpn.springeropen.com ejnpn.springeropen.com/articles/10.1186/s41983-021-00401-5

The effect of bilateral tDCS over dorsolateral prefrontal cortex ... Bilateral DLPFC stimulation resulted in a significant improvement in cognitive flexibility, planning, decision making, inhibitory control/ ...

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.