Adding rTMS to treatment for alcohol or opioid use disorder
rTMS as Add on Treatment for Substance Use Disorders
NA · Yale University · NCT06963476
We will try different types and brain targets of rTMS to see if they reduce drinking in people with alcohol use disorder and reduce opioid use in people with opioid use disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT06963476 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study will deliver different repetitive transcranial magnetic stimulation (rTMS) protocols to participants receiving treatment for Alcohol Use Disorder (AUD) or Opioid Use Disorder (OUD) at a residential center. The study tests whether inhibitory cTBS to the medial prefrontal cortex is better than excitatory iTBS to the left dorsolateral prefrontal cortex for reducing alcohol use, and whether iTBS to the left dlPFC is superior to cTBS at reducing opioid use. Primary feasibility measures include recruitment, completion of the rTMS intervention, and four-week follow-up retention. Key outcomes include treatment engagement, change in drinks per day and heavy drinking days for AUD, and reduction in opioid use for OUD.
Who should consider this trial
Good fit: Adults in treatment for AUD or OUD who can give informed consent in English and do not have contraindications to rTMS (e.g., seizure risk, certain implants) are ideal candidates.
Not a fit: People with a history of seizures, significant neurological injury, implanted electronic devices, acute unstable cardiac disease, or those meeting criteria for clinically significant alcohol withdrawal are excluded and would not be expected to benefit from this rTMS intervention.
Why it matters
Potential benefit: If successful, this approach could offer a noninvasive add-on therapy that helps reduce alcohol or opioid use and improve engagement with prescribed treatments.
How similar studies have performed: Previous rTMS research for substance use disorders has shown mixed but sometimes promising results, while direct head-to-head comparisons of these specific targets and protocols in a residential sample remain novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be able to give valid informed consent in English. * Absence of cognitive impairment: IQ equivalent of ≥ 70 on the WRAT. * Receiving treatment for either AUD or OUD Exclusion Criteria: * History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. * Current meeting withdrawal criteria for alcohol: AUD participants will not meet for clinically significant alcohol withdrawal: Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) ≤ 5. * First-degree family history of epilepsy or multiple sclerosis. * Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes rTMS administration. * Current use of anti- or pro-convulsive action. * Use of benzodiazepines in the last 48 hours prior to rTMS. Benzodiazepines are used during alcohol withdrawal management but then are discontinued prior to recruitment into the study. Therefore, rTMS eligible participants will not continue taking benzodiazepines. * Lifetime history of schizophrenia, bipolar disorder, mania. * History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack. * Pregnant or lactating women. * TMS contraindications. * Treatment center discharge date does not allow for scheduling of all 5 rTMS days
Where this trial is running
Hartford, Connecticut
- Hartford Healthcare — Hartford, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Vaughn R Steele, PhD — Yale University
- Study coordinator: Vaughn R Steele, Ph.D.
- Email: vaughn.steele@yale.edu
- Phone: 860.545.7855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use, Alcohol Use Disorder