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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06081985
Other study ID # 2021TIPF026
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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