CompletedNot Applicable

sTMS for Substance Use-disordered Veterans

United States42 participantsStarted 2021-09-07

Plain-language summary

The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eligible male and female Veterans * between ages 18-70, * Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures * ongoing medications and psychotherapy will be allowed to continue unchanged during the study * for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population Exclusion Criteria: * pregnancy/lactation, * history of moderate or severe traumatic brain injury, * current or prior neurologic disorder or lifetime history of * seizure disorder * CNS tumors * stroke * cerebral aneurysm, * unstable medical condition, * active suicidality as assessed with the Columbia-Suicide Severity Rating Scale * primary psychotic disorder.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)

Timeframe: 6 weeks

substance specific craving

Timeframe: 6 weeks

Social and Occupational Functioning Assessment Scale (SOFAS)

Timeframe: 6 weeks

Trial details

NCT IDNCT04336293

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Cocaine Addiction trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.