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Helping Kentuckians Overcome Depression and Opioid Addiction With Brain Stimulation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares TMS, which uses magnets to stimulate the brain, with a sham (inactive) treatment. It is for adults with opioid addiction who take buprenorphine and still have symptoms of major depression. Researchers will see if TMS reduces depression and opioid cravings, and will track smoking, side effects, and how people feel about the treatment.

This study will compare transcranial magnetic stimulation (TMS) with sham TMS in people with opioid use disorder who are taking buprenorphine and have major depressive disorder with ongoing depressive symptoms. The study will evaluate whether TMS improves depressive symptoms and reduces opioid craving. The study will also assess smoking behaviors, treatment acceptability, and any side effects related to TMS.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 75 years old.
  • Be willing and able to agree to join after learning about the study.
  • Be able to read and speak English.
  • Have opioid addiction that has been in remission (under control) for at least 1 month.
  • Have major depression confirmed by a study interview.
  • Score at least 10 on the study’s 17-item depression rating scale.
  • Rate opioid cravings at least 5 on a scale from 0 to 10.
  • Have been on stable buprenorphine treatment, taken under the tongue or as a long-acting shot, for at least 8 weeks.

Who can't join

  • Have a seizure disorder.
  • Have another current medical or behavioral condition that makes joining unsafe.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Cannot safely have an MRI scan, including because of iron-containing retainers, implants inside the skull, or fear of tight spaces.
  • Have surgery planned during the study.
  • Have another medical condition that could put your well-being at risk.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 18-75 years of age * Willing and able to provide informed consent * Able to read and speak english * Opioid use disorder, in remission for at least a month * Diagnosis of major depressive disorder confirmed with the Mini-International Neuropsychiatric Interview (MINI, 7.02) * Minimum score of 10 on the 17-item Hamilton Depression Rating Scale (HDRS-17) * Opioid craving score of 5 or greater on a 0-10 scale * Stabilized on sublingual or depot buprenorphine for at least 8 weeks Exclusion Criteria: * Seizure disorder * any other acute medical or behavioral disorder that would preclude safe participation * Pregnant, nursing or planning to become pregnant during the study * Magnetic resonance imaging (MRI) contraindications, including ferrous retainers, intracranial implants, or claustrophobia * Surgical procedure planned during the study period * Any other medical condition that could compromise participant well-being

Study sites (1)

KY