Opioid Use Disorder
Conditions
Keywords
Transcranial Magnetic Stimulation, Opioid Use Disorder
Brief 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.
Detailed 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).
Interventions
DEVICETranscranial Magnetic Stimulation with double-cone coil
Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil
Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| craving | 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
| Measure | Time frame | Description |
|---|---|---|
| Impulsivity severity | 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. |
| Depression severity | 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. |
| Anxiety severity | pretreatment, 2 weeks, and 8 weeks | Hamilton Anxiety Rating Scale. The minimum and maximum scores are 0-56. Higher scores mean a worse outcome. |
| Opioid use | 8 weeks of treatment | opioid metabolite in urine. |
Countries
Turkey (Türkiye)
Outcome results
None listed