Opioid Use Disorder, Major Depressive Disorder (MDD)
Conditions
Brief summary
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.
Interventions
DEVICETranscranial Magnetic Stimulation (TMS)
Intermittent theta burst stimulation (iTBS) delivered over the left dorsolateral prefrontal cortex using a TMS coil.
Sham Transcranial Magnetic Stimulation (TMS) delivered using the same procedure as active TMS without a significant electric field induced around the brain.
Sponsors
University of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptom Severity | 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. |
| Change in Opioid Craving | 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. |
Countries
United States
Contacts
CONTACTGopalkumar Rakesh, MD
Outcome results
None listed