Clinical trial for Opiod Use Disorder
Official title Vanderbilt Integrated Community TMS for Opioid Recovery
ClinicalTrials.gov ID: NCT07457489
What this study is testing
- What it's testing
- The study wants to learn how stimulating a specific brain area affects opioid cravings and use. It also looks at brain changes after stimulation.
- Who it's for
- It is for adults who have opioid use disorder and can safely receive TMS and optional MRI scans.
- What's involved
- Participants will attend 12 visits over about 5 months. Each visit lasts 1–2 hours and includes interviews, questionnaires, computer tasks, TMS sessions, and optional MRI scans.
- Time commitment
- The study lasts about 5 months with 12 visits, each 1–2 hours long.
Which group you join is decided by chance.
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 65
You may be able to join if
- Age between 18-65 years
- Diagnosis of OUD according to DSM-5 criteria and confirmed by SCID (First et al. 2015)
- Meets either of the following criteria: (1) reports opioid craving of 2 or greater on a 0-10 scale, or (2) has returned to opioid use at least once...
- Currently Prescribed Buprenorphine for the treatment of opioid use disorder
- Must be able to read, speak and understand English
You likely can't join if
- DSM-5 intellectual disability
- Substance use disorder (other than opioid, nicotine, or cannabis) within the past three months
- Current, active suicidal ideation with intent or plan
- Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
- History of psychosis in the past 3 months or diagnosis of a primary psychotic disorder
- Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease)...
See the full eligibility criteria
- Age between 18-65 years
- Diagnosis of OUD according to DSM-5 criteria and confirmed by SCID (First et al. 2015)
- Meets either of the following criteria: (1) reports opioid craving of 2 or greater on a 0-10 scale, or (2) has returned to opioid use at least once within the past 12 months.
- Currently Prescribed Buprenorphine for the treatment of opioid use disorder
- Must be able to read, speak and understand English
- Must be judged by study staff to be capable of completing the study procedures
- Participants will be in stable outpatient psychiatric treatment and psychiatrically stable.
- DSM-5 intellectual disability
- Substance use disorder (other than opioid, nicotine, or cannabis) within the past three months
- Current, active suicidal ideation with intent or plan
- Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
- History of psychosis in the past 3 months or diagnosis of a primary psychotic disorder
- Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g.
- History of head trauma resulting in any loss of consciousness (\>15 minutes) or neurological sequelae
- Current history of poorly controlled headaches including chronic medication for migraine prevention
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g.
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
- Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
- All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study
- Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration...
- Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit
The study team makes the final eligibility decision.
Where it is enrolling
- Brentwood, Tennessee, United States
- Nashville, Tennessee, 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, but 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Brentwood, Tennessee, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.