Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder

Not Applicable

Completed

• Conditions: Opioid Use Disorder
• Interventions: Device: Transcranial Magnetic Stimulation with sham coil; Device: Transcranial Magnetic Stimulation with double-cone coil

• Registration Number: NCT06081985
• Lead Sponsor: Pamukkale University

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.

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 Timeline

• Study Start: 2021-10-21
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-13
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Age 18- 65
• Clinical diagnosis of opioid use disorder

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TMS	Transcranial Magnetic Stimulation with sham coil	Sham TMS to the left dorsolateral prefrontal cortex with sham coil
Active TMS	Transcranial Magnetic Stimulation with double-cone coil	Deep TMS to the left dorsolateral prefrontal cortex with double-cone coil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Opioid use	8 weeks of treatment	opioid metabolite in urine.
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.

Trial Locations

Locations (1)

Bengu Yucens; 🇹🇷 Denizli, Turkey