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

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation with double-cone coil
Transcranial Magnetic Stimulation with sham coil
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Transcranial Magnetic Stimulation, Opioid Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bengu YucensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active TMS

Sham TMS

Arm Description

Deep TMS to the left dorsolateral prefrontal cortex with double-cone coil

Sham TMS to the left dorsolateral prefrontal cortex with sham coil

Outcomes

Primary Outcome Measures

craving
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
The Barratt Impulsiveness Scale-11 (BIS). The minimum and maximum scores are 30-120. Higher scores mean a worse outcome.
Depression severity
The Hamilton Depression Rating Scale. The minimum and maximum scores are 0-52. Higher scores mean a worse outcome.
Anxiety severity
Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome.
Opioid use
opioid metabolite in urine.

Full Information

First Posted
October 2, 2023
Last Updated
October 8, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT06081985
Brief Title
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
Official Title
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
Transcranial Magnetic Stimulation, Opioid Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TMS
Arm Type
Active Comparator
Arm Description
Deep TMS to the left dorsolateral prefrontal cortex with double-cone coil
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
Sham TMS to the left dorsolateral prefrontal cortex with sham coil
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation with double-cone coil
Intervention Description
Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation with sham coil
Intervention Description
Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil
Primary Outcome Measure Information:
Title
craving
Description
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 Outcome Measure Information:
Title
Impulsivity severity
Description
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
Title
Depression severity
Description
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
Title
Anxiety severity
Description
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
Title
Opioid use
Description
opioid metabolite in urine.
Time Frame
8 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bengu Yucens, M.D.
Phone
+905052633138
Email
dr.bengubaz@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengu Yucens
Organizational Affiliation
Pamukkale University Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Bengu Yucens
City
Denizli
ZIP/Postal Code
20020
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bengü Yücens
Phone
+905052633138
Email
dr.bengubaz@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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