Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2021
CompletedFirst Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedNovember 20, 2024
November 1, 2024
2.4 years
October 2, 2023
November 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Impulsivity severity
pretreatment, 2 weeks, and 8 weeks
Depression severity
pretreatment, 2 weeks, and 8 weeks
Anxiety severity
pretreatment, 2 weeks, and 8 weeks
Opioid use
8 weeks of treatment
Study Arms (2)
Active TMS
ACTIVE COMPARATORDeep TMS to the left dorsolateral prefrontal cortex with double-cone coil
Sham TMS
SHAM COMPARATORSham TMS to the left dorsolateral prefrontal cortex with sham coil
Interventions
Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil
Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil
Eligibility Criteria
You may qualify if:
- Age 18- 65
- Clinical diagnosis of opioid use disorder
You may not qualify if:
- Currently pregnant or breastfeeding
- Mental retardation, bipolar disorder, any psychotic disorder
- Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis
- History of head trauma that resulted in loss of consciousness for ≥5 minutes and retrograde amnesia for ≥30 minutes (self-reported history)
- Any history of seizures other than febrile childhood seizures (self-reported history)
- Clinically significant hearing impairment
- Having any prosthesis, such as an implant and pacemaker.
- Illiteracy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bengu Yucens
Denizli, 20020, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 40536869DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bengu Yucens
Pamukkale University Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Associate Professor
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 13, 2023
Study Start
October 21, 2021
Primary Completion
March 1, 2024
Study Completion
April 1, 2024
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share