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Neuromodulation

Transcranial Direct Current Stimulation (tDCS) for Opioid Use Disorder

N/A

Recruiting

Led By Jazmin Y Camchong, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 2 weeks of abstinence and 2 months later

Awards & highlights

Study Summary

This trial will test whether tDCS can reduce relapse in people with opioid use disorder.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of tDCS include mild discomfort at the electrode site, itching, tingling during application, headache, fatigue, nausea or insomnia post-treatment. Serious side effects are rare but can include mania in vulnerable individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 2 weeks of abstinence and 2 months later

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 2 weeks of abstinence and 2 months later

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 2 weeks of abstinence and 2 months later for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in brain functional connectivity as measured by functional magnetic resonance imaging

Secondary outcome measures

Correlation between functional connectivity change and clinical outcome

Correlation between functional connectivity change and craving scores

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673

back pain flair up

Myasthenia Gravis

100%

80%

60%

40%

20%

Study treatment Arm

tDCS + Robotic Arm Therapy

tDCS Sham + Robotic Arm Therapy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: active tDCSExperimental Treatment1 Intervention

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

Group II: Sham Comparator: sham tDCSPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation (tDCS)

2016

Completed Phase 2

~2100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,384 Previous Clinical Trials

1,552,179 Total Patients Enrolled

Jazmin Y Camchong, PhDPrincipal InvestigatorUniversity of Minnesota

Kelvin O Lim, MDPrincipal InvestigatorUniversity of Minnesota

3 Previous Clinical Trials

280 Total Patients Enrolled

Media Library

tDCS (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT03773523 — N/A

Opioid Use Disorder Research Study Groups: Experimental: active tDCS, Sham Comparator: sham tDCS

Opioid Use Disorder Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT03773523 — N/A

tDCS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03773523 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available opportunities to register for this research project?

"By consulting clinicaltrials.gov, it is evident that this investigation is still recruiting participants. This trial was first launched on August 1st 2019 and the most recent update occurred on March 3rd 2022."

Answered by AI

Does this clinical trial accept participants aged 45 or older?

"Patients aged 18 to 60 may enroll in this trial. In contrast, there are 89 trials for younger participants and 400 studies that accept older people exceeding the age of 65."

Answered by AI

What is the participant count of this clinical research project?

"Yes, the evidence published on clinicaltrials.gov confirms that this medical trial is currently recruiting patients. It was initially shared on August 1st 2019 and its details were last updated as recently as March 3rd 2022. The investigators are looking for 30 individuals from a single site to participate in the study."

Answered by AI

Are there certain criteria for eligibility in this trial?

"This clinical trial is seeking 30 individuals with an opioid use disorder, aged 18 to 60. In order to be admitted, participants must meet the following standards: 20 abstinent persons (in between ages of 18 and 60; 1-2 weeks without opioids) fitting DSM-V criteria for OUD who are partaking in Lodging Plus Program at University of Minnesota Medical Center. This four week program provides a supervised environment where drug screenings take place randomly. The facility has 50 beds that typically accommodate around 20 patients per week, half of whom have been diagnosed with OUD., Must provide written consent as well as comply with study procedures according to Diagn"

Answered by AI

Recent research and studies

Cerebral CortexJournal

Resting-state Synchrony During Early Alcohol Abstinence Can Predict Subsequent Relapse

Camchong, J., A. Stenger, and G. Fein. 2012. “Resting-state Synchrony During Early Alcohol Abstinence Can Predict Subsequent Relapse”. Cerebral Cortex. Oxford University Press (OUP). doi:10.1093/cercor/bhs190.

Drug and Alcohol DependenceJournal

Changes in Resting Functional Connectivity During Abstinence in Stimulant Use Disorder: A Preliminary Comparison of Relapsers and Abstainers

Camchong, Jazmin, Angus W. MacDonald III, Bryon A. Mueller, Brent Nelson, Sheila Specker, Valerie Slaymaker, and Kelvin O. Lim. 2014. “Changes in Resting Functional Connectivity During Abstinence in Stimulant Use Disorder: A Preliminary Comparison of Relapsers and Abstainers”. Drug and Alcohol Dependence. Elsevier BV. doi:10.1016/j.drugalcdep.2014.03.024.

Alcoholism: Clinical and Experimental ResearchJournal

Resting-state Synchrony in Short-term Versus Long-term Abstinent Alcoholics

Camchong, Jazmin, Victor Andrew Stenger, and George Fein. 2013. “Resting-state Synchrony in Short-term Versus Long-term Abstinent Alcoholics”. Alcoholism: Clinical and Experimental Research. Wiley. doi:10.1111/acer.12037.

clinicaltrials.govStudy