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Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week.
The participants will undergo baseline assessments, including rating scales and urine opioid metabolite tests. The participants will receive one of two treatments: High-frequency (10Hz, 3000 pulses per session) dTMS using a double cone coil targeting the left dorsolateral prefrontal cortex or sham stimulation. Each treatment will be preceded by a short-guided imagery (2-3 min) design to activate the relevant brain circuitry (provocation of symptoms may increase the response rate to deep TMS as was evident in the treatment of PTSD, cigarette smoking, and OCD). dTMS sessions will be conducted 10 times per week for 2 weeks, for 20 sessions. 8 weeks of patient follow-up, including clinical visits at weeks 0, 2, and 8. During this phase, subjective and objective measures of opioid use (self-report and analysis of urine samples for opioid metabolite) will be collected. Following the completion of the main part by the individual, an "open-label" treatment using the same parameters of the experiment will be offered (regardless of the treatment group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TMS | Active Comparator | Deep TMS to the left dorsolateral prefrontal cortex with double-cone coil |
|
| Sham TMS | Sham Comparator | Sham TMS to the left dorsolateral prefrontal cortex with sham coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation with double-cone coil | Device | Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil |
|
| Measure | Description | Time Frame |
|---|---|---|
| craving | craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome. | pretreatment, 2 weeks, and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Impulsivity severity | The Barratt Impulsiveness Scale-11 (BIS). The minimum and maximum scores are 30-120. Higher scores mean a worse outcome. | pretreatment, 2 weeks, and 8 weeks |
| Depression severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bengu Yucens | Pamukkale University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bengu Yucens | Denizli | 20020 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40536869 | Derived | Guldas S, Tumkaya S, Yucens B. Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder: A Double-Blind, Placebo-Controlled Randomized Trial. Addict Biol. 2025 Jun;30(6):e70057. doi: 10.1111/adb.70057. |
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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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| Transcranial Magnetic Stimulation with sham coil | Device | Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil |
|
The Hamilton Depression Rating Scale. The minimum and maximum scores are 0-52. Higher scores mean a worse outcome.
| pretreatment, 2 weeks, and 8 weeks |
| Anxiety severity | Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome. | pretreatment, 2 weeks, and 8 weeks |
| Opioid use | opioid metabolite in urine. | 8 weeks of treatment |