Community TMS to reduce opioid craving and support recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18-65 years
2. Diagnosis of OUD according to DSM-5 criteria and confirmed by SCID (First et al. 2015)
3. 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.
4. Currently Prescribed Buprenorphine for the treatment of opioid use disorder
5. Must be able to read, speak and understand English
6. Must be judged by study staff to be capable of completing the study procedures
7. Participants will be in stable outpatient psychiatric treatment and psychiatrically stable.

Exclusion Criteria:

1. DSM-5 intellectual disability
2. Substance use disorder (other than opioid, nicotine, or cannabis) within the past three months
3. Current, active suicidal ideation with intent or plan
4. Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
5. History of psychosis in the past 3 months or diagnosis of a primary psychotic disorder
6. 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
7. History of head trauma resulting in any loss of consciousness (\>15 minutes) or neurological sequelae
8. Current history of poorly controlled headaches including chronic medication for migraine prevention
9. History of fainting spells of unknown or undetermined etiology that might constitute seizures
10. 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
11. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
12. 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)
13. Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
14. 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
15. 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.
16. Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit

Where it's running

• 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
• Email: jillian.connolly@vumc.org
• Phone: 6154345891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.