Actively Recruiting
Vanderbilt Integrated Community Transcranial Magnetic Stimulation for Opioid Use Disorder Recovery
Led by Vanderbilt University Medical Center · Updated on 2026-04-21
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how stimulating a specific brain region affects craving and opioid use in people with opioid use disorder (OUD). The study focuses on individuals taking buprenorphine, a common medication for OUD, and aims to test whether intermittent theta burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L DLPFC) can reduce craving and opioid use. This randomized, sham-controlled trial will help understand if brain stimulation can improve inhibitory control and lower relapse risk in OUD. Participants will receive 8 weekly sessions of FDA-approved iTBS targeting the L DLPFC, with each session consisting of 2 stimulation periods separated by a 50-minute break. Some will receive active iTBS, while others will receive sham stimulation that mimics the experience but does not deliver actual stimulation. Optional brain imaging (MRI) scans will be offered before and after the treatment period to study brain changes. After the 8 weeks of treatment, follow-up visits will occur at weeks 10, 12, and 20, with participants who received sham stimulation offered open-label active iTBS afterward. Participants will attend a total of 12 visits over about 5 months involving interviews, questionnaires, computer tasks, and brain stimulation sessions. Assessments will include measures of opioid craving using self-reports and brain imaging tasks, urine toxicology tests, and evaluations of psychiatric symptoms. Safety will be monitored closely, including screening for seizure risk and potential side effects. Data confidentiality is ensured through secure storage and coded data. The study aims to provide detailed information on changes in craving and opioid use following brain stimulation.
CONDITIONS
Brief Title
Vanderbilt Integrated Community TMS for Opioid Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18-65 years
- Diagnosis of opioid use disorder (OUD) confirmed by DSM-5 criteria and SCID
- Started buprenorphine treatment for OUD within the past 12 months with return to opioid use within that period
- Able to read, speak, and understand English
- Judged capable by study staff to complete study procedures
- Currently in stable outpatient psychiatric treatment and psychiatrically stable
You will not qualify if you...
- Intellectual disability as defined by DSM-5
- Substance use disorder other than opioid, nicotine, or cannabis within past 3 months
- Current active suicidal thoughts with intent or plan
- Positive urine drug screen for substances that increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)
- History of psychosis in past 3 months or diagnosis of primary psychotic disorder
- History of progressive or genetic neurological disorders or acquired neurological diseases
- History of head trauma with loss of consciousness over 15 minutes or neurological effects
- Poorly controlled headaches or chronic migraine medication use
- History of fainting spells of unknown cause that may be seizures
- History of seizures, epilepsy, or first-degree family history of epilepsy except benign single seizure
- Chronic uncontrolled medical conditions that increase seizure risk
- Presence of metal in brain, skull, or body unless cleared by physician
- Implanted devices like pacemakers or nerve stimulators unless cleared by physician
- Pregnancy or planning pregnancy; females must have negative pregnancy test
- Use of medications that affect brain excitability as reviewed by physician
- Any condition or factor that study staff judge unsuitable for participation or tolerance of study visits
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive 8 weekly sessions of FDA-approved L DLPFC-targeted intermittent theta burst stimulation (iTBS) to reduce opioid craving and use. Each weekly visit includes 2 iTBS sessions separated by a 50-minute break during which participants complete questionnaires and provide urine samples.
Weekly visits for 8 weeks with 2 iTBS sessions per visit
Duration - Approximately 12 weeks after treatment
Participants return for follow-up visits to complete questionnaires and provide urine samples to assess opioid craving and use after treatment ends. These visits may be in-person or conducted remotely by phone or video conferencing.
3 visits at weeks 10, 12, and 20
Duration - During treatment period and shortly after
Participants who elect to undergo MRI will have 2 MRI scans, one before treatment begins and one after treatment ends, including cognitive tasks and assessments related to craving and inhibitory control.
2 separate MRI visits
Duration - 8 weeks
Participants who received sham treatment are offered 8 weekly sessions of open-label active iTBS after the week 20 visit to receive the active intervention.
Weekly visits for 8 weeks
Trial Site Locations
Total: 2 locations
1
Synaptic Psych
Brentwood, Tennessee, United States, 37027
Actively Recruiting
2
Vanderbilt University Medical Center Psychiatric Hospital
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
J
Jillian G Connolly, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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