Vanderbilt Integrated Community TMS for Opioid Recovery

NCT07457489 | Recruiting DMC FDA Device

• 2 other identifiers: 251239AWD009875
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Opiod Use Disorder

Keywords

opioid use disorder; TMS; Brain Imaging; L DLPFC

Outcome Measures

Primary Outcomes (1)

• Assessing Changes in Opioid Craving Following L DLPFC-Targeted iTBS Administration through the Visual Analog Scale, Self-Reports, and changes in cue reactivity, as measured during an MRI.

  Aim 1: Determine the effects of an FDA-approved protocol (active L DLPFC-targeted iTBS compared to sham) on craving and opioid use in people with OUD (n=100). Hypothesis: Active DLFPC-targeted iTBS will reduce craving and opioid use in people with OUD. This will be assessed by analyzing responses on a Visual Analog Scale where participants rate their craving for opioids on a scale of 1-10 during each visit. Craving will also be assessed using the cue reactivity task in an MRI to observe changes in brain connectivity during a cue-reactivity task where participants view images of opiods while periodically ranking their craving.

  From the start of the study (screening visit) to the 20 week follow-up visit.

Study Arms (2)

L DLPFC-Targeted iTBS

ACTIVE COMPARATOR

8 weekly sessions of L DLPFC-targeted iTBS.

Device: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

L DLPFC-Targeted Sham TMS

SHAM COMPARATOR

8 weekly sessions of L DLPFC-targeted sham TMS.

Device: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Device: Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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 B70 A/P, MagVenture A/S, Denmark) targeting the L DLPFC is FDA-approved for treatment of depression.

Also known as: iTBS

L DLPFC-Targeted Sham TMS; L DLPFC-Targeted iTBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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) 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
• Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (2)

Synaptic Psych

Brentwood, Tennessee, 37027, United States

RECRUITING

Vanderbilt University Medical Center Psychiatric Hospital

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Heather Ward, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jillian G Connolly, BS

CONTACT

6154345891; jillian.connolly@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)