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NCT Number: NCT07842601

Helping Kentuckians Overcome Depression and Opioid Addiction With Brain Stimulation

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder (MDD) Mental Disorders Mood Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation (TMS)

Device

Intermittent theta burst stimulation (iTBS) delivered over the left dorsolateral prefrontal cortex using a TMS coil.

Sham Transcranial Magnetic Stimulation (TMS)

Device

Sham Transcranial Magnetic Stimulation (TMS) delivered using the same procedure as active TMS without a significant electric field induced around the brain.

Primary outcomes

  1. Change in Depressive Symptom Severity

    Time frame: Baseline through Week 13

    Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline, comparing participants receiving transcranial magnetic stimulation (TMS) with those receiving Shame TMS. Higher scores indicate greater depressive symptom severity. The HDRS-17 ranges from 0-52.

  2. Change in Opioid Craving

    Time frame: Baseline through Week 13

    Change in opioid craving as measured by the Opioid Craving Scale (OCS) from baseline, comparing participants receiving the TMS with those receiving sham TMS. The OCD consists of three items rated 0 to 10, with the total score calculated as the average of the three items. A higher score indicates greater opioid craving.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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