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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation with double-cone coil; Device: Transcranial Magnetic Stimulation with sham coil

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20020
    • Bengu Yucens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Study Director: Bengu Yucens, Pamukkale University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Transcranial Magnetic Stimulation
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2021TIPF026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No