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The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. In this study, individuals will receive 10 sessions of TMS (twice daily for 5 days). The investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment.
The aim of this study is to investigate the effects of transcranial magnetic stimulation (TMS) on craving in individuals treated with buprenorphine for opioid use disorder. Investigators will enroll subjects aged 18-65 years old who are currently in treatment with buprenorphine for opioid use disorder. Included subjects will have initiated treatment with buprenorphine in the last 3 months, be able to read, write, and understand English, and, if female, agree to use contraception. Subjects will be excluded if they have a history of bipolar or psychotic illness, current depression, use substances other than opioids, take medications that lower seizure threshold or impair neuroplasticity, have chronic pain, have a history of seizure or any other uncontrolled medical issue, or have a device or ferromagnetic implant in the head or neck. Enrolled subjects will receive 10 (twice daily for 5 days) sessions of active TMS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (L DLPFC) on consecutive weekdays. Investigators will assess craving, substance use, and mood throughout the study and 1-2 weeks post-treatment completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label Active TMS | Experimental | All subjects will receive open-label treatment with active Transcranial Magnetic Stimulation (TMS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | TMS is a form of noninvasive brain stimulation. An external electromagnetic coil is placed on the head, and a large current is passed through an insulated wire coil held flat on the surface of a subject's scalp in a fraction of a millisecond. This pulse of current induces a weak electrical current within the surface brain cortex. Repetitive trains of TMS pulses (repetitive TMS or rTMS) can transiently modulate corticospinal excitability following the rTMS train. When current is delivered at high frequency (10 Hz), it may simultaneously increase the activity of the brain at this site. In this study, individuals will receive 10 treatments with intermittent theta burst stimulation (twice daily for 5 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Cue-Induced Craving, as measured by 0-100 Visual Analog Scale | Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving) | End of TMS Treatments (1 week) |
| Drug Craving, as measured by 0-100 Visual Analog Scale | Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving) | End of TMS Treatments (1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use) | Timeline Followback calendar, which measures days of opioid use over the past 2 weeks | End of TMS Treatments (1 week) |
| Retention in Buprenorphine Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather B Ward, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments
| End of TMS Treatments (1 week) |
| Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) | Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms | End of TMS Treatments (1 week) |
| Drug Craving, as measured by 0-100 Visual Analog Scale | Visual Analog Scale (0-100, where 0 = no craving, 100 = maximum craving) | 1-2 weeks after completion of TMS treatments |
| Opioid Use and Relapse, as measured by Timeline Followback Calendar (days of opioid use) | Timeline Followback calendar, which measures days of opioid use over the past month | 1-2 weeks after completion of TMS treatments |
| Retention in Buprenorphine Treatment | Treatment Retention: subjects actively engaged in buprenorphine treatment, attending appointments | 1-2 weeks after completion of TMS treatments |
| Symptoms of Depression, as measured by the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) | Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), where higher score indicates more severe depressive symptoms | 1-2 weeks after completion of TMS treatments |
| Neuropsychologic Testing Battery | Penn Computerized Neuropsychologic Battery | End of TMS treatment (1 week) |
| Impulsivity | Barratt Impulsivity Scale | End of TMS treatment (1 week) |