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

Pamukkale University

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Device: Transcranial Magnetic Stimulation with sham coil; Device: Transcranial Magnetic Stimulation with double-cone coil

Study type: Interventional

Funder types: Other

Identifiers

NCT06081985

2021TIPF026

Details and patient eligibility

About

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.

Full 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).

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

Active TMS

Active Comparator group

Description:

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

Treatment:

Device: Transcranial Magnetic Stimulation with double-cone coil

Sham TMS

Sham Comparator group

Description:

Sham TMS to the left dorsolateral prefrontal cortex with sham coil

Treatment:

Device: Transcranial Magnetic Stimulation with sham coil