Trials / Completed
CompletedNCT06081985
Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Pamukkale University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcranial Magnetic Stimulation with double-cone coil | Deep Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with double-cone coil |
| DEVICE | Transcranial Magnetic Stimulation with sham coil | Transcranial Magnetic Stimulation to the Left Dorsolateral Prefrontal Cortex with sham coil |
Timeline
- Start date
- 2021-10-21
- Primary completion
- 2024-03-01
- Completion
- 2024-04-01
- First posted
- 2023-10-13
- Last updated
- 2024-11-20
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06081985. Inclusion in this directory is not an endorsement.