Community TMS to reduce opioid craving and support recovery

Vanderbilt Integrated Community TMS for Opioid Recovery

This program tests whether repetitive transcranial magnetic stimulation (TMS) can reduce craving and opioid use in adults on buprenorphine who have recently returned to opioid use.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 2 sites (Brentwood, Tennessee and 1 other locations)
• Trial ID: NCT07457489 on ClinicalTrials.gov

What this trial studies

Participants will attend 12 in-person visits across about five months that include interviews, questionnaires, computer tasks, and repeated sessions of TMS targeting the left dorsolateral prefrontal cortex, with optional MRI scans used to guide stimulation and measure brain changes. The protocol uses noninvasive rTMS delivered at outpatient clinics to see if strengthening prefrontal inhibitory control lowers craving and relapse risk during the high-risk period after buprenorphine initiation. Eligibility focuses on adults 18–65 with DSM-5 opioid use disorder who started buprenorphine within the past 12 months and have had a return to opioid use, while excluding people with recent psychosis, certain other substance use disorders, seizure risks, or progressive neurologic conditions. Safety monitoring includes screening for seizure risk and monitoring for common minor side effects such as headache, facial twitching, or transient discomfort during stimulation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–65 with DSM-5 opioid use disorder who began buprenorphine within the past year, have experienced return to opioid use, are in stable outpatient psychiatric care, and can complete English-language study procedures.

Not a fit: Patients who may not benefit include those with recent psychosis, active suicidal intent, recent disqualifying substance use (e.g., stimulants, benzodiazepines, cocaine), seizure risk, progressive neurologic disease, or those unwilling/unable to attend in-person TMS or MRI procedures.

Why it matters

Potential benefit: If successful, this approach could lower craving and reduce relapse, helping more people stay on buprenorphine and improve recovery outcomes.

How similar studies have performed: Previous small trials of rTMS targeting prefrontal regions have shown mixed but promising reductions in craving for several substances, though larger definitive trials in opioid use disorder remain limited.

Eligibility criteria

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

Where this trial is running

Brentwood, Tennessee and 1 other locations

• Synaptic Psych — Brentwood, Tennessee, United States (Recruiting)
• Vanderbilt University Medical Center Psychiatric Hospital — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Heather Ward, MD — Vanderbilt University Medical Center
• Study coordinator: Jillian G Connolly, BS

Conditions Opiod Use Disorder; opioid use disorder; TMS; Brain Imaging; L DLPFC