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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081985
• Other study ID #: 2021TIPF026
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Pamukkale University
• Contact: Bengu Yucens, M.D.
• Phone: +905052633138
• Email: dr.bengubaz[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Device:
• Transcranial Magnetic Stimulation with double-cone coil
Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil
• Transcranial Magnetic Stimulation with sham coil
Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil

Locations

Country	Name	City	State
Turkey	Bengu Yucens	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Opioid use	opioid metabolite in urine.	8 weeks of treatment