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Behavioural Intervention

Active FPS for Opioid Use Disorder (FPS_Opioid Trial)

N/A
Waitlist Available
Research Sponsored by Laureate Institute for Brain Research, Inc.
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 immediate before and immediate after intervention
Awards & highlights

FPS_Opioid Trial Summary

This trial is examining whether a non-invasive brain stimulation technology called transcranial alternating current stimulation (tACS) can help reduce drug craving in people with opioid use disorder (OUD).

Eligible Conditions
  • Opioid Use Disorder

FPS_Opioid Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate before and immediate after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate before and immediate after intervention 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 Drug Cue Reactivity BOLD Signal in fMRI from before to after Intervention
Secondary outcome measures
Change in Cortical-Subcortical Connectivity in Resting State fMRI from before to after Intervention
Change in Drug Cue Reactivity Self-Report from before to after Intervention
Other outcome measures
Change in Area Under Electrode Connectivity in Resting State fMRI from before to after Intervention
Change in Area Under Electrode Task-based Connectivity in Cue Exposure fMRI from before to after Intervention
Change in Cortical-Subcortical Task-based Connectivity in Cue Exposure fMRI from before to after Intervention
+3 more

FPS_Opioid Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active FPSExperimental Treatment1 Intervention
We use Starstim AC (alternative current) -Stimulator R32. FPS protocol will be used with 20 minutes 2mAmp 6 Hz tACS to the middle frontal gyrus (DLPFC, F4 in EEG electrodes with 10-20 system measurement) and inferior parietal cortex (IPC, P4), as the main nodes of the frontoparietal network, in synchronous oscillation. The 4 return electrodes will receive 0.5 mAmp each around each active electrode (High Definition Montage). The electrodes are silver/silver chloride that are wet with conductive gel. We will use surface landmarks and EEG caps on the head to place the electrodes, which are held in place by head caps with holes indicating places for electrode positioning.
Group II: Sham FPSPlacebo Group1 Intervention
In the sham stimulation mode, the device shows pseudorandom numbers on the screen that look like real stimulation is being delivered. The device gives a low level of stimulation at the very beginning and at the very end of the stimulation session (30 seconds ramp up and 30 seconds ramp down) in order to recreate the feeling of tingling that subjects perceive at the beginning and end of real stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Alternating Current Stimulation (tACS)
2019
N/A
~130

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
50 Previous Clinical Trials
5,285 Total Patients Enrolled
Brain & Behavior Research FoundationOTHER
61 Previous Clinical Trials
2,754 Total Patients Enrolled

Frequently Asked Questions

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

Is there a specific demographic that is eligible to participate in this research?

"This trial is enrolling 60 individuals, aged 18-61 years old and male, who are currently suffering from Opioid Use Disorder (OUD). The diagnosis of OUD must have been established within the last year through a DSM V structured interview."

Answered by AI

Is there currently an open enrollment period for this particular clinical trial?

"As per the information available on clinicaltrials.gov, recruitment for this trial is currently underway. Initially posted in March 15th 2019 and last updated May 3rd 2022, applicants are welcome to submit their applications."

Answered by AI

How many participants have enrolled in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment started recruitment on March 15th 2019 and was recently modified on May 3rd 2022. The research team needs 60 participants from a single site for their data collection activities."

Answered by AI

Does the research project admit participants over eighty-five years of age?

"The minimum age of entry for this trial is 18 and the maximum permitted age is 61, as specified in the eligibility criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Frontoparietal Synchronization to Modulate Drug Craving in Opioid Use Disorder
2019. "Frontoparietal Synchronization to Modulate Drug Craving in Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03907644.
~10 spots leftby Apr 2025
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