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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
20 abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-60 years old, have not used opioids for 1-2 weeks, and have been diagnosed with opioid use disorder.
Select...
I plan to stay in the Lodging Plus program for 4 weeks until the study ends.

Timeline

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
3%
back pain flair up
3%
Myasthenia Gravis
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,377 Previous Clinical Trials
1,588,266 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
~5 spots leftby May 2025