Helping Kentuckians Overcome Depression and Opioid Addiction With Brain Stimulation

ConditionsOpioid Use Disorder Major Depressive Disorder (MDD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorUniversity of Kentucky

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Transcranial Magnetic Stimulation (TMS)Experimental treatment 1 intervention

Group B: Sham Transcranial Magnetic Stimulation (TMS)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Depressive Symptom Severity

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.

Time frame

Baseline through Week 13

Change in Opioid Craving

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.

Time frame

Baseline through Week 13

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Kentucky

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: