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OpenTrials
Completed

NCT Number: NCT06081985

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bengu Yucens

Denizli, 20020, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation with double-cone coil

Device

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

Transcranial Magnetic Stimulation with sham coil

Device

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

Primary outcomes

  1. craving

    Time frame: pretreatment, 2 weeks, and 8 weeks

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

Secondary outcomes

  1. Impulsivity severity

    Time frame: pretreatment, 2 weeks, and 8 weeks

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

  2. Depression severity

    Time frame: pretreatment, 2 weeks, and 8 weeks

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

  3. Anxiety severity

    Time frame: pretreatment, 2 weeks, and 8 weeks

    Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome.

  4. Opioid use

    Time frame: 8 weeks of treatment

    opioid metabolite in urine.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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