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Stress Pharmacotherapy + rTMS for Opioid Use Disorder

Phase 2
Waitlist Available
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-60 yr
Use alcohol and/or marijuana <3 times/week; each 'time' should consist of <1 marijuana 'joint' equivalent and <3 alcoholic drinks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)
Awards & highlights

Study Summary

This trial is designed to see if stress impacts domains of behavior in individuals with opioid use disorder, and whether transcranial magnetic stimulation (TMS) can help attenuate negative effects of stress.

Who is the study for?
This trial is for right-handed individuals aged 21-60 with opioid use disorder who are not seeking treatment. They must have a stable heart rate and blood pressure, consume alcohol or marijuana minimally, and be cognitively intact. Exclusions include pregnancy, certain drug use, seizure history, unstable illnesses, lactose intolerance, recent participation in other studies, and specific mental health diagnoses.Check my eligibility
What is being tested?
The study tests how rTMS (a non-invasive brain stimulation) versus sham (fake treatment) combined with pharmacological stress (using Yohimbine + Hydrocortisone vs placebo) affects executive function and opioid-seeking behavior in people with OUD. It aims to see if rTMS can reduce the negative effects of stress on behavior.See study design
What are the potential side effects?
Possible side effects may include discomfort at the rTMS application site on the scalp, headache or lightheadedness post-treatment. The pharmacological stress might cause increased heart rate or anxiety temporarily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 60 years old.
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I use alcohol and/or marijuana less than 3 times a week, within the specified limits.
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My heart rate and blood pressure are within safe ranges.
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I am a male or a female not currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Color-Word Stroop Task
Delay Discounting Task
Diastolic blood pressure
+14 more
Secondary outcome measures
Opioid agonist symptoms
Opioid craving
Opioid withdrawal symptoms

Side effects data

From 2022 Phase 2 trial • 72 Patients • NCT03144232
27%
Headache
16%
Fatigue
3%
Eye twitch
3%
Jaw Pain
3%
Site discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: placebo stressor, active rTMSExperimental Treatment2 Interventions
Placebo stressor (lactose) + active 10Hz rTMS over the left dlPFC
Group II: active stressor, sham rTMSExperimental Treatment2 Interventions
Stressor (yohimbine 54mg + hydrocortisone 20mg) + sham (inactive) rTMS over the left dlPFC
Group III: active stressor, active rTMSExperimental Treatment2 Interventions
Stressor (yohimbine 54mg + hydrocortisone 20mg) + active 10Hz rTMS over the left dlPFC
Group IV: placebo stressor, sham rTMSPlacebo Group2 Interventions
Placebo stressor (lactose) + sham (inactive) rTMS over the left dlPFC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active rTMS
2019
Completed Phase 2
~350
Placebo
1995
Completed Phase 3
~2670
Sham rTMS
2008
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,444 Total Patients Enrolled

Media Library

Active rTMS Clinical Trial Eligibility Overview. Trial Name: NCT04231708 — Phase 2
Opioid Use Disorder Research Study Groups: placebo stressor, sham rTMS, placebo stressor, active rTMS, active stressor, sham rTMS, active stressor, active rTMS
Opioid Use Disorder Clinical Trial 2023: Active rTMS Highlights & Side Effects. Trial Name: NCT04231708 — Phase 2
Active rTMS 2023 Treatment Timeline for Medical Study. Trial Name: NCT04231708 — Phase 2

Frequently Asked Questions

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

Are you seeking more participants for this research?

"As of 4/26/2022, this clinical trial is no longer recruiting patients. The first posting was on 1/1/2023 and there have been no edits since then. However, if the patient is looking for other studies, 555 trials for opioid abuse and 64 Active rTMS trials are still admitting participants."

Answered by AI

What other research has been conducted with Active rTMS?

"There are currently 64 ongoing trials for Active rTMS. 20 of those trials are in the third and final stage. Most of these studies are taking place New york, though there are 3041 research sites in total running these tests."

Answered by AI

Can you provide some examples of Active rTMS's common applications?

"Active rTMS is a common treatment for pupil, but it can also be used to help patients with ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

To whom does this research pertain?

"This clinical trial, which is only recruiting 20 participants in total, is currently looking for individuals aged 21 to 60 years old who have a history of opioid abuse."

Answered by AI

Does the FDA condone Active rTMS?

"Active rTMS falls into the category of being a Phase 2 trial, which means that while there is data indicating it is safe, there is no evidence yet to support its efficacy. Our team at Power rates Active rTMS as a 2 on safety."

Answered by AI

How many people are included in the data sample for this research?

"Presently, this study is not enrolling patients. The trial was first posted on January 1st 2023 and was most recently updated on April 26th 2022. However, there are 555 other studies actively recruiting participants with opioid abuse and 64 trials for Active rTMS that are still open."

Answered by AI

Are test subjects for this experiment restricted to a certain age group?

"The specific requirements to enroll in this trial are that patients must be aged 21-60. However, there are 125 other trials available for minors and 441 different research programs targeting senior citizens."

Answered by AI
~13 spots leftby Oct 2026