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RECRUITING

NCT07457489

Vanderbilt Integrated Community TMS for Opioid Recovery

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

The main purpose of this study is to learn how stimulating a region in the brain influences craving and opioid use. The brain will be stimulated using TMS. Participants may choose to receive brain imaging (magnetic resonance imaging, MRI) as part of this study. The MRI will be used to identify areas in the brain that to stimulate and to measure brain changes as a result of TMS. Participants will be asked to attend a total of 12 visits over about 5 months. Each visit will last between 1-2 hours with breaks. The study will involve interviews, questionnaires, computer tasks, TMS, and optional MRIs. There are minor risks associated with this study. Answering some of the study questionnaires may cause stress or fatigue. The physical risks of TMS are low. Participants may experience mild pain or headache during or after receiving TMS. These symptoms may extend to adjacent areas of the face. The discomfort may be associated with twitching or movement of these areas during stimulation. This is generally transient and can be treated with over-the-counter pain medication. To minimize any risk of hearing loss during TMS, participants wear earplugs for the entire procedure. An evaluation of the participant's medical history will also be completed to ensure that it will be safe for participants to receive TMS. There is no direct benefit to participants from being in this study. However, participation may help others in the future as a result of knowledge gained from the research. The physical risks of the optional MRI are minimal, and a health questionnaire will be filled out before to determine if it is safe for participants to complete the MRI. Confidentiality: All efforts, within reason, will be made to keep personal information in participants' research records confidential but total confidentiality cannot be guaranteed. Documents containing identifiable subject information, like this consent form, will be stored in locked filing cabinets located in the Departments of Psychiatry and Radiology at Vanderbilt. Electronic files containing identifiable information will be stored on password protected systems at Vanderbilt. If a Week 10, 12, or 20 study visit is conducted over video-conferencing, links to the video-call will be sent only to the research participant and approved staff. Video-calls will take place in private locations where the risk of someone hearing or seeing the research visit is minimized. Subjects will be assigned a numeric code that will be used to label all research data, including brain imaging scans. Only Dr. Ward and approved research staff will have access to this data. Only de-identified data will be stored on this server. Disclosures that participants consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that participants make are also not protected. Privacy: Any samples and information about participants may be made available to others to use for research. To protect privacy, participant's name's will not be released. Participants will not receive any benefit as a result of the tests done on samples. These tests may help us or other researchers learn more about the causes, risks, treatments, or how to prevent this and other health problems. Study Results: Participant's individual study results will not be shared with them. The final results of the study will potentially be published in the scientific literature.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-01

Completion Date

2028-01-01

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Opiod Use Disorder

Interventions

DEVICE

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Participants will receive 8 weekly sessions of FDA-approved L DLPFC-targeted iTBS (Weeks 1-8). Prior to the first TMS visit, individuals will be randomized to receive active or sham iTBS. For the sham condition, the iTBS coil will be flipped 180 degrees so that the sham iTBS looks and sounds like active iTBS but delivers no actual stimulation to the participant. At each TMS visit, participants will receive 2 sessions of iTBS separated by 50 minutes, as in the FDA-approved protocol for depression (Cole et al. 2022; Cole et al. 2020). Participants will complete questionnaires during the 50-minute break, allowing for maximum efficiency. All rTMS will be administered at the Vanderbilt Psychiatric Hospital. The MagPro coil used in this study (Cool B65 A/P, MagVenture A/S, Denmark) targeting the L DLPFC is FDA-approved for treatment of depression.

DEVICE

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

For the sham condition, the iTBS coil will be flipped 180 degrees so that the sham iTBS looks and sounds like active iTBS but delivers no actual stimulation to the participant. The procedure will be identical to that of the L-DLPFC iTBS, but the coil will be flipped for each treatment. All sham rTMS will be administered at the Vanderbilt Psychiatric Hospital. The MagPro coil used in this study (Cool B65 A/P, MagVenture A/S, Denmark).

Inclusion Criteria: * Age between 18-65 years * Diagnosis of OUD according to DSM-5 criteria and confirmed by SCID * Started taking buprenorphine for OUD in the past 12 months and had return to use of opioids in the past 12 months * 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. Exclusion Criteria: * 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. stroke, traumatic brain injury, tumor), including intracranial lesions * 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. febrile seizures) in the judgment of a board-certified neurologist * 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 of treatment, and use of CNS active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures. * Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit

Locations (2)

Synaptic Psych

Brentwood, Tennessee, United States

Vanderbilt University Medical Center Psychiatric Hospital

Nashville, Tennessee, United States