Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active TMS Deep TMS to the left dorsolateral prefrontal cortex with double-cone coil |
Device: Transcranial Magnetic Stimulation with double-cone coil
Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil
|
| Sham Comparator: Sham TMS Sham TMS to the left dorsolateral prefrontal cortex with sham coil |
Device: Transcranial Magnetic Stimulation with sham coil
Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil
|
Outcome Measures
Primary Outcome Measures
- craving [pretreatment, 2 weeks, and 8 weeks]
craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome.
Secondary Outcome Measures
- Impulsivity severity [pretreatment, 2 weeks, and 8 weeks]
The Barratt Impulsiveness Scale-11 (BIS). The minimum and maximum scores are 30-120. Higher scores mean a worse outcome.
- Depression severity [pretreatment, 2 weeks, and 8 weeks]
The Hamilton Depression Rating Scale. The minimum and maximum scores are 0-52. Higher scores mean a worse outcome.
- Anxiety severity [pretreatment, 2 weeks, and 8 weeks]
Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome.
- Opioid use [8 weeks of treatment]
opioid metabolite in urine.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18- 65
-
Clinical diagnosis of opioid use disorder
Exclusion Criteria:
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Currently pregnant or breastfeeding
-
Mental retardation, bipolar disorder, any psychotic disorder
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Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis
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History of head trauma that resulted in loss of consciousness for ≥5 minutes and retrograde amnesia for ≥30 minutes (self-reported history)
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Any history of seizures other than febrile childhood seizures (self-reported history)
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Clinically significant hearing impairment
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Having any prosthesis, such as an implant and pacemaker.
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Illiteracy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bengu Yucens | Denizli | Turkey | 20020 |
Sponsors and Collaborators
- Pamukkale University
Investigators
- Study Director: Bengu Yucens, Pamukkale University Faculty of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021TIPF026