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

N/ACompletedNCT06081985

Pamukkale University55 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Opioid Use Disorder

Interventions

Transcranial Magnetic Stimulation with double-cone coilDEVICE

Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil

Transcranial Magnetic Stimulation with sham coilDEVICE

Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Bengu Yucens

Denizli, Turkey (Türkiye)

Outcomes

Primary Outcomes

craving

craving severity for drug use- Visual Analog Scale (VAS). The minimum and maximum values are 0-10. Higher scores mean a worse outcome.

Time frame: pretreatment, 2 weeks, and 8 weeks

Secondary Outcomes

Impulsivity severity

The Barratt Impulsiveness Scale-11 (BIS). The minimum and maximum scores are 30-120. Higher scores mean a worse outcome.

Time frame: pretreatment, 2 weeks, and 8 weeks

Depression severity

The Hamilton Depression Rating Scale. The minimum and maximum scores are 0-52. Higher scores mean a worse outcome.

Time frame: 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.

Time frame: pretreatment, 2 weeks, and 8 weeks

Opioid use

opioid metabolite in urine.

Time frame: 8 weeks of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.