Optimization of NIBS for Treatment of Addiction

  • STATUS
    Recruiting
  • participants needed
    58
  • sponsor
    Case Western Reserve University
Send
Updated on 16 February 2024
See if I qualify
psychiatric disorder
opioid
opioid use
chronic pain
drug use
opiates
transcranial direct current stimulation
narcotic use

Summary

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

Details
Condition Pain, Pain, Chronic Pain, Chronic Pain, Opioid Use Disorder
Age 18years - 85years
Treatment Active Comparator: Active tDCS + Active TUS, Sham Comparator: Sham tDCS + Sham TUS
Clinical Study IdentifierNCT04379115
SponsorCase Western Reserve University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Providing informed consent to participate in the study
18 to 85 years old
Having a diagnosis of OUD, in the setting of CP
OUD of more than 6 months duration as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) [64] and with a positive hair follicle test (i.e., opioid use in the last ~90 days), OR a positive urine toxicology screen
and CP per the American Society of Interventional Pain Physicians (ASIPP) International Association for the Study of Pain (IASPP) [65], having pain for at least 6 months, and not responding to first line therapies
Lives in the immediate area with no plans to relocate

Exclusion Criteria

The subject is pregnant
Recently started on antiepileptic drug therapy
History of illegal drug abuse (except for opioids) within the past 6 months as selfreported
Ingestion of poppy seeds or herbal teas containing Papaveris Fructus (may cause a positive opiate test for morphine, codeine [66, 67])
History of neurological disorders involving stroke, brain tumors, or epilepsy as selfreported (note patients will also be evaluated via electroencephalography (EEG) at baseline 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed))
History of unexplained fainting spells as self-reported
History of head injury resulting in more than a momentary loss of consciousness as self-reported
History of brain surgery as self-reported
Contraindications to tDCS applied in conjunction with TUS
Metal in the head, or
Implanted brain medical devices
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory (BDI), PHQ-910)
Active malignancy
History of suicidal behavior or suicide attempts
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

psychiatric disorder
opioid
opioid use
chronic pain
drug use
opiates
transcranial direct current stimulation
narcotic use

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.