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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-21

Study Completion Date

2024-04-01

Brief Summary

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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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Detailed Description

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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).

Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active TMS

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

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation with double-cone coil

Intervention Type DEVICE

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

Sham TMS

Sham TMS to the left dorsolateral prefrontal cortex with sham coil

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation with sham coil

Intervention Type DEVICE

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

Interventions

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Transcranial Magnetic Stimulation with double-cone coil

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

Intervention Type DEVICE

Transcranial Magnetic Stimulation with sham coil

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No