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New treatment option for Opioid-use Disorder
Official title Optimization of NIBS for Treatment of Addiction
ClinicalTrials.gov ID: NCT04379115
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Participants must meet all of the following:
- Provide informed consent
- Age 18-85 years
- Diagnosis of opioid use disorder (DSM-5) with ongoing non-prescription opioid use confirmed by self-report and urine toxicology
- Report current opioid craving
You likely can't join if
- Participants will be excluded if they:
- Are pregnant
- Have frequent illicit stimulant use or acute stimulant intoxication
- Are using substances or medications that may interfere with study assessments (e.g., stimulant medications, buprenorphine-based therapies, naltrexone)
- Have significant neurological conditions (e.g., stroke, epilepsy, brain tumor), abnormal EEG findings, history of brain surgery, significant head...
- Have contraindications to noninvasive brain stimulation (e.g., metal in the head, implanted brain devices)
See the full eligibility criteria
- Participants must meet all of the following:
- Provide informed consent
- Age 18-85 years
- Diagnosis of opioid use disorder (DSM-5) with ongoing non-prescription opioid use confirmed by self-report and urine toxicology
- Report current opioid craving
- Enrolled in a certified Opioid Treatment Program and receiving methadone maintenance treatment
- Stable methadone dose prior to enrollment
- Reside locally with no plans to relocate during the study
- Participants will be excluded if they:
- Are pregnant
- Have frequent illicit stimulant use or acute stimulant intoxication
- Are using substances or medications that may interfere with study assessments (e.g., stimulant medications, buprenorphine-based therapies, naltrexone)
- Have significant neurological conditions (e.g., stroke, epilepsy, brain tumor), abnormal EEG findings, history of brain surgery, significant head injury, or unexplained syncope
- Have contraindications to noninvasive brain stimulation (e.g., metal in the head, implanted brain devices)
- Have moderate to severe depression or active suicidal ideation/behavior
- Have active malignancy
- Consume substances that could confound opioid toxicology results (e.g., poppy-seed products)
The study team makes the final eligibility decision.
Where it's taking place
- Hinsdale, Illinois, United States
- Cambridge, Massachusetts, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hinsdale, Illinois, United States; Cambridge, Massachusetts, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.