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Stress Pharmacotherapy + rTMS for Opioid Use Disorder
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 72 Patients • NCT03144232Trial Design
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Who is running the clinical trial?
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- You are not allowed to be under the influence of any drugs or alcohol during the session.I don't have medical conditions that prevent me from using rTMS.I am not taking medications that lower seizure threshold, psychiatric drugs, prescription painkillers, or blood pressure medications.You have been diagnosed with opioid use disorder according to the DSM-5 guidelines.I have ongoing pain in my head or neck.I am between 21 and 60 years old.You have had substance abuse problems in the past year, except for opioid use disorder (OUD).You have been diagnosed with certain mental health disorders, such as psychotic disorder, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, or major depression within the past 5 years. If a clinical psychologist determines that your behavior could be disruptive or unsafe in the lab, you may also be excluded if you potentially have antisocial personality disorder.I use alcohol and/or marijuana less than 3 times a week, within the specified limits.My heart rate and blood pressure are within safe ranges.You have good mental abilities, with an IQ score of more than 80 on a test called the Shipley Institute of Living Scale.You have used illegal drugs (except marijuana) other than opioids in the past week.I am a male or a female not currently pregnant or breastfeeding.I do not have any severe illnesses that would make it unsafe for me to participate.
- Group 1: placebo stressor, sham rTMS
- Group 2: placebo stressor, active rTMS
- Group 3: active stressor, sham rTMS
- Group 4: active stressor, active rTMS
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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