Helping Kentuckians Overcome Depression and Opioid Addiction With Brain Stimulation

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
University of Kentucky
Study ID
NCT07842601
Status
Not Yet Recruiting

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Conditions

  • Major Depressive Disorder (MDD)
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcranial Magnetic Stimulation (TMS)
    Participants will receive active transcranial magnetic stimulation (TMS) using intermittent theta burst stimulation (iTBS).
  • Sham Comparator: Sham Transcranial Magnetic Stimulation (TMS)
    Participants will receive sham transcranial magnetic stimulation (TMS) using the same treatment procedure without a significant electric field induced around the brain.

Primary Outcome Measure

Change in Depressive Symptom Severity [ Time Frame: Baseline through Week 13 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Gopalkumar Rakesh, MD
[email protected]
8592579402

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By research site
University of Kentucky· Lexington, KY

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