Clinical trial NCT06963476: rTMS as Add on Treatment for Substance Use Disorders
Official title: rTMS as Add on Treatment for Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use
Alcohol Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals receiving treatment from Hartford Health Care (HHC) for AUD or OUD will be recruited.
Primary purpose: TREATMENT

Brief summary: This pilot study is designed to test feasibility and superiority of rTMS types and target locations for the optimal rTMS intervention for individuals seeking treatment for Alcohol Use Disorder (AUD) or Opioid Use Disorder (OUD).

The critical questions this study seeks to answer are: which rTMS type applied to l-dlPFC in OUD participants will induce the greatest reduction of opioid use post-treatment? Is inhibitory rTMS applied to medial prefrontal cortex (mPFC) more effective than excitatory rTMS applied to l-dlPFC at reducing alcohol use post treatment in AUD participants?

Detailed description: Aim 1: To assess feasibility of applying rTMS within a residential treatment center. Feasibility will be assessed by 1) recruitment of sufficient numbers of AUD and OUD participants; 2) completion of the rTMS intervention; 3) retention of follow-up at the 4-week interval.

Aim 2: To assess superiority of mPFC cTBS compared to l-dlPFC iTBS to reduce alcohol use in AUD patients post-treatment. Superiority will be assessed by evaluating 1) treatment engagement at the 4-week interval (e.g., number of prescribed AUD treatments addended); 2) reduction of drinks/day post-treatment, compared to pre-treatment; 3) reduction of heavy drinking days (e.g., \>5 drinks/day) post-treatment, compared to pre-treatment.

Aim 3: To assess superiority of l-dlPFC iTBS to l-dlPFC cTBS to reduce opioid use in OUD patients post-treatment. Superiority will be assessed by evaluating 1) treatment engagement at the 4-week interval (e.g., number of prescribed OUD treatments addended); 2) reduction of opioids used post-treatment, compared to pre-treatment.

Eligibility 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

Primary outcomes:
measure: Number of participants that successfully complete the study
timeFrame: 4-weeks post-treatment
measure: Mean number of drinks per day
timeFrame: 4-weeks post-treatment
measure: Mean number of heavy drinking days
timeFrame: 4-weeks post-treatment
measure: Opioid use
timeFrame: 4-weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
Study officials:
affiliation: Yale University
name: Vaughn R Steele, PhD
role: PRINCIPAL_INVESTIGATOR
References: